[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"barrett-esophagus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:barrett-esophagus":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,44,74,98,122,146,179,195,213,237,259,284,306,348,377,399,422,441,464,487,511,537,563,584,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054289","phase-2-itraconazole-in-combination-with-ablation-for-the-prevention-of-esophageal-cancer-in-patients-with-high-risk-barretts-esophagus-100054289",false,"NCT06732388","Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus","Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients With High-risk Barrett's Esophagus in Combination With Ablation","Inclusion Criteria:\n\n* Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC), naïve to treatment, and being considered for ablation.\n\n  * Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two pathologists. The two pathologists could include a pathologist from the referring site and an institutional pathologist at the local enrolling site, two pathologists from the referring site, or two pathologists from the local enrolling site. The diagnosis between two pathologists has to be concordant regarding the presence of dysplasia or cancer. Discrepant diagnoses will be resolved by a third pathologist, if needed\n* Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \\\u003C 18 years of age, children are excluded from this study\n* Clinically eligible for EGD and endoscopic treatment of BE\n* Absolute neutrophil count ≥ 1,000\u002Fmicroliter\n* Platelets ≥ 100,000\u002Fmicroliter\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (≤ 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e. Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional upper limit of normal\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* There are no controlled data on the effects of itraconazole on the developing human fetus at the recommended therapeutic dose. For this reason and because azoles are known to be teratogenic, women of child-bearing potential must agree to use one or more methods of highly effective contraception that do not contain estrogen (e.g. progestin only oral contraceptive, non-hormonal intrauterine device, bilateral tubal ligation) two months prior to study entry, for the duration of study participation and two months after completing the study drug. Women should not donate eggs or participate in in vitro fertilization for the duration of study participation, and two months after completing the study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Male subjects should avoid donating sperm, and if engaged in intercourse with women of child-bearing potential use a method of highly effective contraception.\n\n  * Activities of Reproductive Potential: In addition to heterosexual intercourse, activities that could lead to pregnancy (e.g. sperm or egg donation, participation in in vitro fertilization) should be considered when evaluating the reproductive potential of clinical trial subjects.\n  * Females of Reproductive Potential: A non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure. A female who has had a tubal ligation sterilization, or hysterectomy would not be considered to be of reproductive potential unless participating in activities of reproductive potential other than heterosexual intercourse (e.g. egg donation, participation in in vitro fertilization).\n  * Menopause:\n\n    * Twelve (12) months of spontaneous amenorrhea or;\n    * Spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \\> 40 mIU\u002FmL or;\n    * Subject is post-bilateral oophorectomy with or without hysterectomy\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Current New York Heart Association (NYHA) class III or IV congestive heart failure\n* Prolonged corrected QT (QTc) (\\> 450 ms for men and \\> 470 ms for women)\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole\n* Uncontrolled intercurrent illness., or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with itraconazole, breastfeeding should be discontinued if the mother is treated with itraconazole\n* Critical drug interactions (grades D or higher) with other medications metabolized by cytochrome P450(CYP)3A4 (if the medication cannot be discontinued or switched or dose modified); these decisions will be made on a case-by-case basis by the site investigators in consultation with the treating provider. Drug interactions can be assessed using one of the available on-line resources, for instance, UpToDate or Clinical Formulary and\u002For in collaboration with a clinical pharmacist.\n\n  * Note: If there are potential drug interactions that do not exclude the participant from the study, a brief research note summarizing the decision-making process about potential drug interactions and their management will be required before the participants are enrolled in the trial\n* History of eosinophilic esophagitis\n* History of strictures not allowing passage of the radiofrequency ablation (RFA) assembly\n* Participants must not have evidence of active\u002Frecurrent invasive cancer of a non-esophageal organ\n* Participants with EAC greater than stage T1a\n* Persistent (\\> 24 hour \\[h\\]) systolic blood pressure (BP) greater than or equal to 160 mmHg (to avoid reaching hypertensive crisis defined as systolic BP \\> 180 mmHg)\n* Patients taking eliglustat. Co-administration of itraconazole and eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6","ALL","18 Years",{"count":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial tests how well itraconazole works in combination with the usual standard of care endoscopy with ablation for the prevention of esophageal cancer in patients who have high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes and becomes more like the tissue that lines the intestine. People with Barrett's esophagus have a higher risk of developing esophageal cancer. Itraconazole is a drug used to prevent or treat fungal infections. Ablation refers to the removal of abnormal tissue using heat. Endoscopy is a procedure for looking at the esophagus using a long, flexible tube called an endoscope, which has a video camera at the end. Radiofrequency ablation is a type of heat therapy that uses radiofrequency energy (similar to microwave heat) to destroy the abnormal tissue in the esophagus. Giving itraconazole in combination with standard of care endoscopy with ablation may improve the effects of ablation and prevent esophageal cancer in patients with high-risk Barrett's esophagus.",[27,28,29,30],"Barrett Esophagus","Clinical Stage I Esophageal Adenocarcinoma AJCC v8","Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8","Esophageal Adenocarcinoma","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2026-06-23",{"date":39,"type":21},"2030-12-01",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",6,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100480004","seattle-biopsy-protocol-versus-wide-area-transepithelial-sampling-in-patients-with-barretts-esophagus-undergoing-surveillance-100480004","NCT05530343","Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance","A Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)","SWAT-BE","Inclusion Criteria:\n\nSurveillance Population\n\n* Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia\u002Findefinite for dysplasia with NDBE at last endoscopy can be included)\n* Barrett's esophagus (BE) length of at least M1\n* English and Spanish speaking\n* Able to comprehend and complete the consent form\n* Age18-89 years\n* Life-expectancy of at least 2 years\n\nScreening Population\n\n* Undergoing endoscopy for screening of BE\n* BE length of at least M1\n* English and Spanish speaking\n* Able to comprehend and complete the consent form\n* Age 18-89 years\n* Expected life-expectancy of at least 2 years\n\nPhysicians\n\n-All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study.\n\nExclusion Criteria:\n\nSurveillance Population\n\n* BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC)\n* Active erosive esophagitis with LA Grade B or higher\n* Esophageal varices\n* Prior history of EET\n* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication\n* Pregnancy\n\nScreening Population\n\n* BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC\n* Active erosive esophagitis with LA Grade B or higher\n* Esophageal varices\n* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication\n* Pregnancy","89 Years",{"count":54,"type":21},2298,[56],"NA","The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).\n\nBarrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer.\n\nEndoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells.\n\nPatients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).\n\nPatients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE.\n\nWhile both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other.\n\nParticipants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized.\n\nUp to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.",[27,59,30],"Barretts Esophagus With Dysplasia",[61,30,62],"Barrett's Esophagus","Dysplasia","2026-06-29",{"date":65,"type":35},"2026-07-01",{"date":67,"type":35},"2022-10-03",{"date":69,"type":21},"2026-06",{"name":71,"class":72},"University of Colorado, Denver","OTHER",14,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100429093","a-study-comparing-the-effectiveness-of-endorotor-versus-radiofrequency-in-treating-barretts-esophagus-100429093","NCT04867590","A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus","A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia","ENDOBARRETT","Inclusion Criteria:\n\n* Adult patients presenting Barrett's esophagus of a size between 2 cm and 6 cm in the height of the longest tonguea with low to high grade dysplasia that is histologically proven or with a superficial non-invasive adenocarcinoma that has been resected a The total height of the BE is evaluated according to the Prague classification, with the height of the circumferential segment between 0 cm (non-circumferential segment) and 6 cm (segment shaped like a full sleeve for 6 cm), referred to as C0 to C6, and the height of the longest tongue between 2 cm and 6 cm (M2- M6).\n* Patients must have signed the consent form in order to participate in the study\n* Patients are pre-included (signature of consent) before the histological confirmation of dysplasiab and\u002For superficial non-invasive adenocarcinoma that allows the patient to be included in the study.\n\nExclusion Criteria:\n\n* Individuals over 85 years old\n* Women who are pregnant, breastfeeding or in labour\n* Individuals in detention through judicial or administrative decision\n* Individuals who are the subject of psychiatric treatment under duress\n* Individuals who are subjects of legal protection measures\n* Individuals who are in no state to give their consent\n* Individuals who do not understand French or do not know how to read\n* Individuals who are not part of a social security program or benefit from such a scheme\n* Those with active peptic and\u002For radiation-induced or complicated esophagitis at the time of treatment\n* Presence of a visible lesion that is suspected to be esophageal cancer confirmed by biopsies\n* Anterior resection of invasive adenocarcinoma using endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with invasion of the lateral and\u002For deep margin, adenocarcinoma of poorly differentiated characteristics or sub-mucosal invasion \\> 500µm (pT1b)\n* All preliminary ablation treatments or dilation for esophageal stenosis\n* Significant esophageal stenosis: cannot be passed with a standard gastroscope\n* Presence of esophageal varices or portal hypertension\n* Anticoagulant treatment that cannot be stopped before the intervention (excluding 100 mg maximum per day of aspirin in single-drug treatment) or any haemostasis problems that cannot be corrected\n* Having a contraindication regarding anaesthesia\n* Patients incapable of taking proton pump inhibitors (PPIs) orally.",{"count":83,"type":21},140,[56],"Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8\u002F1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls.\n\nA new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.",[27,62],"2026-06-25",{"date":89,"type":35},"2026-06-30",{"date":91,"type":35},"2022-03-25",{"date":93,"type":21},"2031-07-25",{"name":95,"class":96},"University Hospital, Angers","OTHER_GOV",17,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100608825","minimally-invasive-approaches-for-the-diagnosis-of-barretts-esophagus-and-esophageal-cancer-sos5c-trial-100608825","NCT07206589","Minimally Invasive Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Cancer, SOS5C Trial","Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma- R01 Aim 1a Renewal (SOS5C Trial)","Inclusion Criteria:\n\n* SPECIFIC AIM 1A: Adult patients 18-85 years old\n* SPECIFIC AIM 1A INTERVENTION CLUSTERS: BE Risk Tool Score \\> 0.087, indicating a higher risk for BE\u002Fesophageal adenocarcinoma (EAC). This will be run as a web-based application integrating data from several domains in the electronic health record (EPIC). Output score will range from 0-1.\n* SPECIFIC AIM 1A CONTROL CLUSTERS: Meeting American College of Gastroenterology (ACG) screening criteria (gastroesophageal reflux disease \\[GERD\\]+ \\> 2 BE risk factors: Age ≥ 50 years, Male sex, Caucasian race, obesity \\[body mass index (BMI) \\> 30\\], ever smoker, family history of BE\u002FEAC)\n* SPECIFIC AIM 1B: A \"low risk\" BE risk tool score (\\\u003C 0.0897)\n\nExclusion Criteria:\n\n* SPECIFIC AIM 1A: History of Barrett's esophagus or esophageal adenocarcinoma\n* SPECIFIC AIM 1A: Prior endoscopy in the last 10 years\n* SPECIFIC AIM 1A: Patients who are unable to consent\n* SPECIFIC AIM 1A: Patients with a current history of uninvestigated dysphagia\n* SPECIFIC AIM 1A: History of eosinophilic esophagitis, achalasia\n* SPECIFIC AIM 1A: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to the sponge procedure\n* SPECIFIC AIM 1A: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to the sponge procedure\n* SPECIFIC AIM 1A: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure\n* SPECIFIC AIM 1A: Patients with a history of known varices or cirrhosis\n* SPECIFIC AIM 1A: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma\n* SPECIFIC AIM 1A: Patients with congenital or acquired bleeding diatheses\n* SPECIFIC AIM 1A: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma\n* SPECIFIC AIM 1A: Patients with limited life expectancy (\\\u003C 2 years): per provider judgement\n* SPECIFIC AIM 1B: History of Barrett's esophagus or esophageal adenocarcinoma\n* SPECIFIC AIM 1B: Prior endoscopy in the last 10 years\n* SPECIFIC AIM 1B: Patients who are unable to consent\n* SPECIFIC AIM 1B: Patients with a current history of uninvestigated dysphagia\n* SPECIFIC AIM 1B: History of eosinophilic esophagitis, achalasia\n* SPECIFIC AIM 1B: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to procedure\n* SPECIFIC AIM 1B: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to procedure\n* SPECIFIC AIM 1B: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to procedure\n* SPECIFIC AIM 1B: Patients with a history of known varices or cirrhosis\n* SPECIFIC AIM 1B: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma\n* SPECIFIC AIM 1B: Patients with congenital or acquired bleeding diatheses\n* SPECIFIC AIM 1B: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma\n* SPECIFIC AIM 1B: Patients with limited life expectancy (\\\u003C 2 years): per provider judgement",true,"85 Years",{"count":108,"type":21},1010,[56],"This clinical trial studies how well minimally invasive approaches (an artificial intelligence \\[AI\\] powered risk tool, nurse navigation, and a sponge on a string \\[SOS\\] test) work in diagnosing patients with Barrett's esophagus (BE) and esophageal cancer. Esophageal cancer has a poor 5-year survival rate when diagnosed after onset of symptoms. While rising, incidence of esophageal cancer remains too low to screen the entire population. BE is a condition in which the cells lining the lower part of the esophagus have changed or been replaced with abnormal cells that could lead to esophageal cancer. Currently, patients are screened for BE based on certain risk factors (reflux, age \\> 50 years, White race, family history of esophageal cancer, obesity, male sex, and smoking), followed by endoscopies and surgery for treatment. These standard procedures may result in under-recognition of BE risk due to inaccurate and difficult to use risk assessment tools, high cost, invasiveness, low access to endoscopy, and sub-optimal recognition of abnormal cells during routing endoscopy. An AI powered risk tool that integrates symptoms, health history, and laboratory values from electronic health record data may more accurately assess BE and esophageal cancer risk that manual assessment. The BE-SOS screening test combines a swallowable cell collection device with assessment of DNA, which may more accurately diagnose abnormal cells. Nurse navigation involves trained personnel assisting individuals through the screening process and completing the follow-up diagnostic test if the screening test is positive. Navigators address cultural, social, access, and logistical barriers to screening. Nurse navigation may increase completion rates of diagnostic procedures following a positive screening test. These minimally invasive approaches may enable higher rates of BE screening than currently being accomplished.",[27,30],"NOT_YET_RECRUITING",{"date":114,"type":35},"2026-06-24",{"date":116,"type":21},"2026-12-01",{"date":118,"type":21},"2030-07-31",{"name":120,"class":72},"Mayo Clinic",3,{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100521611","assessment-of-a-minimally-invasive-collection-device-for-molecular-analysis-of-esophageal-samples-100521611","NCT06071845","Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples","Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia","SOS4C","Inclusion Criteria:\n\n* Subjects with known or suspected Barrett's esophagus (BE) (cases)\n\n  * Patients between the ages of 18-90.\n  * Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.\n  * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.\n  * Undergoing clinically indicated endoscopy.\n* Subjects without known history of BE (controls)\n\n  * Undergoing clinically indicated diagnostic endoscopy\n\nExclusion Criteria:\n\n* For subjects with or without known evidence of BE (on history or review of medical records)\n\n  * Pregnant or lactating females.\n  * Patients who are unable to consent.\n  * Patients with current history of uninvestigated dysphagia.\n  * History of eosinophilic esophagitis, achalasia.\n  * Patients on oral anticoagulation including Coumadin, Warfarin.\n  * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure.\n  * Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure.\n  * Patients with history of known esophageal or gastric varices or cirrhosis.\n  * Patients with history of surgical esophageal resection for esophageal carcinoma.\n  * Patients with congenital or acquired bleeding diatheses.\n  * Patients with a history of esophageal squamous dysplasia.\n  * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.\n  * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.","90 Years",{"count":132,"type":21},450,[56],"This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE\u002Fesophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE\u002FEAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE\u002FEAC.",[27,59,136,30],"Barrett's Esophagus Without Dysplasia","2026-05-29",{"date":139,"type":35},"2026-06-02",{"date":141,"type":35},"2023-10-16",{"date":143,"type":21},"2027-06-01",{"name":120,"class":72},5,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":154,"enrollmentInfo":155,"targetDuration":157,"studyType":158,"phases":4,"briefSummary":159,"conditions":160,"keywords":165,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100639694","pilot-study-of-salivary-bile-acids-and-pepsin-as-predictive-biomarkers-of-reflux-disease-after-sleeve-gastrectomy-100639694","NCT07607067","Pilot Study of Salivary Bile Acids and Pepsin as Predictive Biomarkers of Reflux Disease After Sleeve Gastrectomy","Prospective Pilot Study of Salivary Bile Acids and Pepsin as Predictive Biomarkers of Reflux Disease and Esophageal Injury After Sleeve Gastrectomy","ABSORB","Inclusion Criteria:\n\n* Adults aged 18 years or older undergoing sleeve gastrectomy at a participating center.\n* Indication for obesity treatment with sleeve gastrectomy according to the 2022 ASMBS-IFSO consensus criteria, with a maximum body mass index (BMI) of 50 kg\u002Fm².\n* Approved for sleeve gastrectomy by the obesity multidisciplinary committee.\n* Ability and willingness to provide informed consent for biological sample collection and analysis.\n* Ability to understand and comply with scheduled follow-up visits.\n\nExclusion Criteria:\n\n* According to Lyon 2.0 criteria, participants with previous evidence of conclusive reflux disease, including Los Angeles grade B, C, or D esophagitis, peptic stricture, or Barrett's esophagus diagnosed before surgery.\n* Bariatric procedures other than sleeve gastrectomy, including Roux-en-Y gastric bypass or revisional bariatric surgery.\n* History of other preexisting esophageal diseases.\n* Previous esophageal surgery.\n* Active cholestatic hepatobiliary disease or treatment with bile acid sequestrants, ursodeoxycholic acid, or medications that significantly alter bile acid metabolism at the time of saliva sampling or within one month before sample collection.\n* Acute infection or systemic antibiotic treatment within four weeks before saliva sample collection.\n* Pregnancy or breastfeeding.","65 Years",{"count":156,"type":21},60,"3 Years","OBSERVATIONAL","The goal of this observational study is to learn whether bile acids and pepsin in saliva can help identify adults at higher risk of developing reflux-related esophageal disease after sleeve gastrectomy, including Los Angeles grade B-D erosive esophagitis and Barrett's esophagus. The study will include adults undergoing sleeve gastrectomy as part of their regular clinical care. Participants will be evaluated before and after surgery and will serve as their own comparison group over time.\n\nThe main questions it aims to answer are:\n\nAre saliva bile acids and pepsin linked to Los Angeles grade B-D erosive esophagitis or Barrett's esophagus after sleeve gastrectomy? How do saliva bile acids and pepsin change before and after sleeve gastrectomy? Can saliva bile acids and pepsin become useful biomarkers for detecting reflux-related esophageal disease after sleeve gastrectomy? Are saliva biomarker levels linked to reflux symptoms and endoscopy results after surgery?\n\nResearchers will compare saliva biomarker levels before and after surgery and between participants with and without reflux-related esophageal disease.\n\nParticipants will:\n\nProvide saliva samples before surgery and at 12 and 36 months after surgery Provide fasting and post-meal saliva samples Undergo routine postoperative clinical follow-up and upper gastrointestinal endoscopy Complete reflux symptom questionnaires during follow-up\n\nThe study will also explore whether saliva biomarkers could help select participants for follow-up endoscopy after sleeve gastrectomy.",[161,162,163,164,27],"Reflux Disease, Gastro-Esophageal","Sleeve Gastrectomy","Saliva Collection","Reflux Esophagitis (RE)",[166,167,168,169,27],"sleeve gastrectomy","bile acid reflux","salivary biomarkers","erosive esophagitis","2026-05-19",{"date":172,"type":35},"2026-05-26",{"date":174,"type":21},"2026-12",{"date":176,"type":21},"2029-12",{"name":178,"class":72},"Hospital de Mataró",{"id":180,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":25,"conditions":186,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":43},"100572370","Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients With High-Risk Barrett's Esophagus in Combination With Ablation","Inclusion Criteria:\n\n* Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC), naïve to treatment, and being considered for ablation.\n\n  * Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two pathologists. The two pathologists could include a pathologist from the referring site and an institutional pathologist at the local enrolling site, two pathologists from the referring site, or two pathologists from the local enrolling site. The diagnosis between two pathologists has to be concordant regarding the presence of dysplasia or cancer. Discrepant diagnoses will be resolved by a third pathologist, if needed\n* Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \\\u003C 18 years of age, children are excluded from this study\n* Clinically eligible for EGD and endoscopic treatment of BE\n* Absolute neutrophil count ≥ 1,000\u002Fmicroliter\n* Platelets ≥ 100,000\u002Fmicroliter\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (≤ 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e. Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional upper limit of normal\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* There are no controlled data on the effects of itraconazole on the developing human fetus at the recommended therapeutic dose. For this reason and because azoles are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) two months prior to study entry, for the duration of study participation and two months after completing the study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Current New York Heart Association (NYHA) class III or IV congestive heart failure\n* Prolonged corrected QT (QTc) (\\> 450 ms for men and \\> 470 ms for women)\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole\n* Uncontrolled intercurrent illness., or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with itraconazole, breastfeeding should be discontinued if the mother is treated with itraconazole\n* Critical drug interactions (grades D or higher) with other medications metabolized by cytochrome P450(CYP)3A4 (if the medication cannot be discontinued or switched or dose modified); these decisions will be made on a case-by-case basis by the site investigators in consultation with the treating provider. Drug interactions can be assessed using one of the available on-line resources, for instance, UpToDate or Clinical Formulary and\u002For in collaboration with a clinical pharmacist.\n\n  * Note: If there are potential drug interactions that do not exclude the participant from the study, a brief research note summarizing the decision-making process about potential drug interactions and their management will be required before the participants are enrolled in the trial\n* History of eosinophilic esophagitis\n* History of strictures not allowing passage of the radiofrequency ablation (RFA) assembly\n* Participants must not have evidence of active\u002Frecurrent invasive cancer of a non-esophageal organ\n* Participants with EAC greater than stage T1a",{"count":184,"type":21},64,[24],[27,28,29,30],"2026-05-12",{"date":189,"type":35},"2026-05-13",{"date":191,"type":21},"2026-10-06",{"date":193,"type":21},"2030-02-01",{"name":41,"class":42},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100434584","phase-2-obeticholic-acid-for-prevention-in-barretts-esophagus-100434584","NCT04939051","Obeticholic Acid for Prevention in Barrett's Esophagus","Inclusion Criteria:\n\n* Known diagnosis of histologically-confirmed BE with either no dysplasia, indefinite for dysplasia, or low-grade dysplasia as defined by the presence of specialized columnar epithelium on histology and \\>= 2 cm of involvement on endoscopy\n* Adequate Barrett's mucosa, which is defined as at least one sample with \\>= 50% intestinal metaplasia in biopsies required to satisfy the endpoints of the study\n* Participants are on proton pump inhibitors (PPI) therapy for \\>= 28 days duration\n* Age \\>= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants \\\u003C 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%)\n* Hemoglobin \\>= 10g\u002FdL or hematocrit \\>= 30 %\n* Leukocyte count \\>= 3,500\u002Fmicroliter\n* Platelet count \\>= 100,000\u002Fmicroliter\n* Creatinine clearance (calculated if measured is not available) \\>= 30mL\u002Fmin\u002F1.73m\\^2\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 1.5 X institutional upper limit of normal (ULN)\n* Total bilirubin =\\\u003C 1.0 X ULN\n* Alkaline phosphatase =\\\u003C1.5 X ULN\n* Gamma-glutamyl transferase (GGT) =\\\u003C 1.5 X ULN\n* The effects of OCA on the developing human fetus are unknown. For this reason, all men and women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of study participation, and for at least 6 months after receiving the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Non-English speaking participants are allowed to enroll even if they skip answering quality-of-life (QOL) questionnaires. Special efforts will be made through community advisory boards at participating sites to reach Spanish speaking participants\n* Willing to undergo testing for human immunodeficiency virus (HIV) testing if not tested within the past 6 months\n* Willing to undergo hepatitis B and C screening if not tested within the past 6 months\n* Willing and able to adhere to the prohibitions and restrictions specified in the approved protocol\n* Willingness to moderate alcohol intake (consuming no more than 1 or 2 alcoholic drinks per day for women and men, respectively)\n* Participants must have no evidence of active or recurrent invasive cancer for 6 months prior to screening and must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation)\n\nExclusion Criteria:\n\n* History of prior ablative therapy such as radiofrequency ablation, cryotherapy or argon plasma coagulation (APC) in BE segment\n* Prior use of OCA\n* Prior history or presence of high-grade disease (HGD) or cancer on pre-intervention endoscopy\n* Cutaneous diseases manifesting with severe pruritus\n* Individuals with active, known or suspected chronic liver disease including cirrhosis, nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis, primary sclerosing cholangitis, biliary atresia\n* Individuals with acute cholecystitis (defined by a syndrome of right upper quadrant pain, fever, and leukocytosis associated with gallbladder inflammation)\n* Individuals with a history of pancreatitis or pancreatic abnormalities\n* Individuals with hepatic steatosis and velocity \\> 1.7 m\u002Fsec as determined by liver ultrasound elastography. Results of a right upper quadrant ultrasound with elastography performed within 6 months of starting study treatment may be used to assess this criteria\n* Individuals with hyperlipidemia that is not well controlled with the use of pharmacotherapy and\u002For dietary modifications\n* History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof\n* Individuals with known hypersensitivity, allergies, or intolerance to the study drug or compounds of similar chemical or biologic composition\n* Any serious and\u002For unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Individuals with active and untreated hepatitis C virus (HCV) and\u002For or hepatitis B virus (HBV) infection\n* Individuals with HIV infection are eligible for participation if:\n\n  * CD4+ count \\>= 300\u002FuL\n  * Viral load is undetectable\n  * Receiving highly active antiretroviral therapy (HAART) without known or suspected drug interactions with OCA\n  * Consultation with the participant's infectious disease specialist may be obtained\n* Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 5 half-lives days prior to starting OCA or placebo on this study. Consultation with the participant's primary care provider may be obtained but is not required.\n\n  * The use of the following drugs or drug classes is prohibited during OCA\u002Fplacebo treatment\n\n    * Investigational agents;\n    * Bile acid sequestrants (bile acid binding resins): cholestyramine, colestipol, or colesevelam;\n    * Bile salt efflux pump (BSEP) inhibitors;\n    * Clozapine;\n    * Theophylline derivatives;\n    * Tizanidine;\n    * Warfarin;\n    * Hepatotoxic drugs such as amiodarone, sodium valproate, certain herbal\u002Fdietary supplements, and long-term doxycycline or tetracycline\n* Pregnant, breast-feeding, or women of childbearing potential unwilling to use a reliable contraceptive method. Pregnant women are excluded from this study because OCA is an agent with unknown effects on the developing human fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OCA, breastfeeding should be discontinued if the mother is treated with OCA\n* Participants may not be receiving any other investigational agents",{"count":202,"type":21},30,[24],"This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression.",[27,30],{"date":189,"type":35},{"date":208,"type":35},"2024-01-03",{"date":210,"type":21},"2027-09-01",{"name":41,"class":42},8,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100449486","longitudinal-oral-microbiome-sampling-for-be-100449486","NCT05133102","Longitudinal Oral Microbiome Sampling for BE","Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus","Inclusion Criteria:\n\n* Scheduled for an upper endoscopy or had upper endoscopy within past three years\n* Eighteen years of age or older\n* Capable of producing a saliva sample\n* Able to give informed consent\n* For BE patients only: Endoscopic evidence of Barrett's esophagus (at least 1 cm maximal BE length; i.e. Prague classification: any C, M≥1), and intestinal metaplasia present on esophageal biopsies\n\nExclusion Criteria:\n\n* History of head and neck cancer or esophageal squamous cell or gastric cancer\n* History of esophageal or gastric surgery\n* Scheduled to undergo colonoscopy on the day of initial saliva collection\n* Scheduled only for Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopy ultrasound (EUS) without accompanying standard upper endoscopy on the day of initial saliva collection\n* For BE patients only: History of prior endoscopic therapy for BE except a history of prior Endoscopic mucosal resection (EMR) of focal lesions without subsequent ablative therapy is permitted",{"count":221,"type":21},275,"This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years.",[27],[225,226,227],"Saliva","Sampling","Oral Microbiome","2026-05-08",{"date":187,"type":35},{"date":231,"type":35},"2021-03-19",{"date":233,"type":21},"2027-08",{"name":235,"class":72},"Columbia University",2,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100602670","impact-of-rfa-on-esophageal-distensibility-and-mucosal-impedance-100602670","NCT07126535","Impact of RFA on Esophageal Distensibility and Mucosal Impedance","Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* Confirmed histologic diagnosis of BE with dysplasia or intramucosal carcinoma (IMCa)\n* Ability to take high-dose proton pump inhibitor (PPI) therapy (such as omeprazole 40 mg BID)\n* Willing to undergo multiple rounds of endoscopic eradication therapy (EET) for management of BE (which is the guideline clinical recommendation for management of this disease)\n\nExclusion Criteria:\n\n* History of esophageal ablation\n* History of esophageal stricture\n* History of esophageal or gastric surgery\n* Pregnancy\n* History of esophageal cancer treated with radiation or chemotherapy\n* History of achalasia\n* History of delayed gastric emptying confirmed by 4-hour gastric emptying study\n* Received injection of glucagon like peptide 1 agonists within a few days prior to EGD\n* Adults lacking the capacity to consent for self",{"count":245,"type":21},10,"Patients undergoing ablative therapy for management of dysplastic Barrett's Esophagus (BE) will have decreased distensibility over the course of treatment, but improvement in mucosal impedance as BE epithelia is replaced by neosquamous epithelia. This information may lead to further research in predicting therapeutic response and complications. The purpose of this research is to collect information while measuring changes related to the esophagus in patients that receive radiofrequency ablation (RFA) for dysplastic Barrett's Esophagus (BE) or esophageal cancer. Study participation includes measurements of the esophagus with the use of two different devices. This takes place during clinically indicated upper endoscopies during the timeframe the participant is receiving RFA treatments. This process will take up to an additional 10 minutes during the upper endoscopy and be done while the participant is sedated.",[248,249,27],"Dysplastic Barrett's Esophagus","Radiofrequency Ablation","2026-03-26",{"date":252,"type":35},"2026-03-30",{"date":254,"type":35},"2025-08-19",{"date":256,"type":21},"2027-07-31",{"name":120,"class":72},1,{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":268,"studyType":158,"phases":4,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":258},"100386507","clinical-utility-of-wats3d-a-5-year-prospective-study-100386507","NCT04312633","Clinical Utility of WATS3D: A 5-Year Prospective Study","CDx Study 906: The Clinical Utility of WATS3D (Wide Area Transepithelial Sampling With Computer-Assisted 3-Dimensional Analysis): A 5- Year Prospective Registry","Inclusion Criteria:\n\n* Able to read, comprehend and complete the IRB-approved consent form\n* Aged 18 or older\n* Meet one of the following:\n* Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or\n* Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or\n* Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation or cryoablation) who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM)\n* Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included.\n\nExclusion Criteria:\n\n* Pregnancy at time of endoscopy\n* Unresolved drug or alcohol dependency that will limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines\n* Medical condition that will likely prohibit completion of a 5 year study",{"count":267,"type":21},90000,"5 Years","The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.",[27,271,272,273],"Gastro Esophageal Reflux","Esophageal Dysplasia","Esophageal Diseases","2026-03-18",{"date":276,"type":35},"2026-03-20",{"date":278,"type":35},"2020-04-01",{"date":280,"type":21},"2027-11-01",{"name":282,"class":283},"CDx Diagnostics","INDUSTRY",{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":294,"conditions":295,"keywords":296,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":258},"100577871","non-endoscopic-detection-of-barretts-esophagus-using-methylation-biomarkers-on-endosign-cell-collection-device-samples-100577871","NCT06803927","Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples","Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples","DETECT-ME","High Risk Screening: Closed November 2025 Barrett's Esophagus Inclusion Criteria\n\n* Undergoing a standard of care EGD (with or without endoscopic eradication therapy {EET})\n* Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD\u002FEET or day of EGD\u002FEET).\n* Willing and able to sign informed consent\n* Confirmed Barrett's Esophagus of length at least 1 cm or greater. This includes non-dysplastic Barrett's, low-grade dysplasia, high-grade dysplasia or adenocarcinoma.\n\nExclusion Criteria\n\n* Previous EGD result was indefinite for dysplasia\n* Previous endoscopic eradication therapy (EET)\n* Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm dia.))\n* Known or suspected gastric or esophageal varices\n* Known or suspected portal hypertension\n* Taking anti-thrombotic medications that cannot be discontinued\n* Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration\n* Previous gastric or esophageal surgery (including Nissen fundoplication)\n* History of oropharyngeal tumor\n* History of myocardial infarction or cerebrovascular accident in past 6 months\n* Known or suspected to be pregnant (self-report for woman of child-bearing potential)",{"count":293,"type":21},700,"This study is looking at cells collected from the esophagus using a diagnostic device called the EndoSign® Cell Collection Device (a sponge on a thread). Subjects swallow a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread. These cells will be tested to check for a condition called \"Barrett's Esophagus.\"\n\nThe cells from the sponge will be tested using Cyted Health biomarkers and compared to the results from a regular endoscopy and any biopsies that are taken. To do this, we need sponge samples from people who might have Barrett's Esophagus based on their risk factors, and from people with Barrett's Esophagus.\n\nSubjects will have one visit to have the Endosign Cell Collection Device administered prior to having a standard of care endoscopy. They will answer some questions about their medical history and experience with the cell collection procedure as part of the study. Data will be collected from medical records including post-endoscopy.",[27],[297,298],"Endosign® Cell Collection Device","Barretts Esophagus","2026-03-16",{"date":274,"type":35},{"date":302,"type":35},"2025-02-05",{"date":174,"type":21},{"name":305,"class":283},"Cyted Health Inc",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":323,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":245},"100627960","a-study-of-barretts-esophagus-patients-optimization-of-a-risk-model-to-better-predict-the-development-of-cancer-recurrence-and-the-effect-of-risk-profile-disclosure-on-patient-quality-of-life-and-fear-of-cancer-100627960","NCT07455422","A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurrence and the Effect of Risk Profile Disclosure on Patient Quality of Life and Fear of Cancer","A Randomized Controlled Trial Using Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early ESOPHAGEAL ADENOCARCINOMA for Assessing Effects on Quality of Life, Cancer Worry and Defining Cost-Effective Surveillance Strategies","Endeavor-2","Inclusion Criteria:\n\n* Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of T1 oesophageal Barrett cancer\n* Capable of receiving informed consent and of giving permission\n* Age 18 and upward\n\nExclusion Criteria:\n\n* Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion\n* Patients refusing randomization and corresponding follow-up intervals based on biomarker profile\n* Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease)\n* Esophageal varices\n* Uncontrollable coagulation disorders\n* Undergoing\u002Fplanned chemotherapy or immunotherapy or received chemotherapy \\\u003C 6 months prior to endoscopy\n* Undergoing\u002Fplanned radiotherapy within the esophageal region or received radiotherapy \\\u003C 6 months prior to endoscopy\n* WHO score \\>3",{"count":315,"type":21},266,[56],"The goal of the study is:\n\n* The collection of various tissue samples (blood, biopsies and \"esophageal brushes\") and their analysis.\n* To test a risk model based on genetic analyses (DNA-FISH and so-called single cell sequencing) on esophageal tissue samples.\n* Evaluating the quality of life of Barrett's Esophagus patients and the degree of fear of getting cancer.\n\nPatients with a Barrett's Esophagus can participate in the study if they are minimally 18 years old, are capable of giving informed consent (fully understanding what the study entails before giving consent to participate), have Barrett Esophagus and are referred to one of the participating centers due to suspicion of early esophageal cancer, for which the participant will be evaluated by endoscopic imaging and biopsy.\n\nStudy procedures:\n\nAn intake consultation will be planned, wherein the eligibility criteria will be assessed, and participant characteristics will be collected.\n\nA routine gastroscopy will be planned twice during which several minimally-invasive interventions will be performed: drawing a blood sample, brush cytology during the endoscopy (a brush is used to obtain cells from the surface of the esophagus) and obtaining biopsy samples (small pieces of tissue). Each participant will need to undergo all the interventions.\n\nPatients will have to complete questionnaires at several time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).\n\nThis study is a randomized trial, meaning the study participants will be divided into two groups by the computer. One group will be informed of their risk profile, established based on the genetic analyses. The other group will not be informed of their risk profile. All patients will be followed-up in a more intensive surveillance schedule compared to the standard of care, for study purposes.",[27,319,320,321,322],"Barrett Esophagus Adenocarcinoma","Adenocarcinoma - GEJ","Gastroenterology","Gastroenterological Cancer",[27,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338],"Barrett","DNA FISH","Genetic profiling","Adenocarcinoma","Brush cytology","Cancer worry","Disease free survival","Randomized controlled trial","RCT","Endoscopic mucosal resection","Endoscopic submucosal dissection","EMR","ESD","Quality of life","Health-Economic analysis","2026-03-02",{"date":341,"type":35},"2026-03-06",{"date":343,"type":21},"2026-06-01",{"date":345,"type":21},"2030-12-31",{"name":347,"class":72},"University Hospital, Antwerp",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":363,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":258},"100542683","molecular-assessment-for-gastro-esophageal-cancer-100542683","NCT06346054","Molecular Assessment for Gastro-Esophageal Cancer","MAGEC","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any breath or blood analysis\n2. \\>18 years old\n3. Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV\n4. Voluntary healthy controls\n\nExclusion Criteria:\n\n1. \\\u003C18 years old\n2. Patient has history of:\n\n   1. Active other cancer than gastro-esophageal cancer\n   2. Prior cancer treated \\\u003C3 years ago\n   3. Hepatic dysfunction\u002Fliver failure (MELT \\>7)\n3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan.\n4. Insufficient\u002Funreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample)\n5. Incarcerated individuals","100 Years",{"count":357,"type":21},1000,[56],"The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.\n\nThe main questions this study aims to answer:\n\nAre oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.\n\nParticipants will provide a breath and blood sample during their routine standard of care visits.",[361,362,27],"Esophageal Cancer","Gastric Cancer",[364,365,366,367],"Oncometabolites","Early-stage cancer","Diagnostic testing","Screening","2026-02-14",{"date":370,"type":35},"2026-02-17",{"date":372,"type":35},"2024-08-01",{"date":374,"type":21},"2029-07-01",{"name":376,"class":72},"KU Leuven",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":336,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":385,"studyType":158,"phases":4,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":258},"100475214","endoscopic-submucosal-dissection-esd-100475214","NCT05468008","Endoscopic Submucosal Dissection (ESD)","Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in Western Population","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled to undergo ESD\n\nExclusion Criteria:\n\n* Any contraindication to performing endoscopy\n* Participation in another research protocol that could interfere or influence the outcomes measures of the present study.",{"count":357,"type":21},"12 Months","This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic submucosal dissection. All patients will receive standard of medical care and no experimental interventions will be performed.",[388,27,389],"Esophageal Lesion","Gastrointestinal Lesions","2026-01-29",{"date":392,"type":35},"2026-02-02",{"date":394,"type":35},"2022-02-04",{"date":396,"type":21},"2027-12",{"name":398,"class":72},"AdventHealth",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100359582","minimally-invasive-molecular-approaches-for-the-diagnosis-of-barretts-esophagus-and-esophageal-adenocarcinoma-100359582","NCT03961945","Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma","Inclusion Criteria Aim1:\n\n* Male and female ages 50-85\n* Patients who have three or more risk factors for Barrett's Esophagus.\n* Gastroesophageal reflux disease defined by:\n\n  * Diagnosis\n  * Use of one of the following drugs \\>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine\n  * prior endoscopic diagnosis of erosive esophagitis\n* Body mass index (BMI) \\>= 30\n\nExclusion Criteria Aim1 and Aim 3:\n\n* Previous history of:\n\n  * esophageal adenocarcinoma\u002Fcancer\n  * esophageal squamous carcinoma\n  * endoscopic ablation for Barrett's esophagus\n  * esophageal squamous dysplasia\n* Current treatment with oral anticoagulation including Warfarin, Coumadin\n* History of cirrhosis\n* History of esophageal\u002Fgastric varices\n* History of Barrett's esophagus\n* Prior endoscopy in the last 5 years\n\nInclusion criteria Aim 2 and Aim 3:\n\n* Subjects with known or suspected BE (cases).\n\n  * Patient between the ages 18 - 90.\n  * Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.\n  * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.\n  * Undergoing clinically indicated endoscopy.\n* Subjects without known history of BE (controls).\n\n  * Undergoing clinically indicated diagnostic endoscopy.\n\nExclusion criteria Aim 2:\n\n* Subjects with known BE.\n\n  * Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)\u002Fendoscopic submucosal dissection (ESD) alone will not be excluded.\n  * Patients with history of esophageal resection for esophageal carcinoma.\n* For subjects with or without known evidence of BE (on history or review of medical records):\n\n  * Pregnant or lactating females.\n  * Patients who are unable to consent.\n  * Patients with current history of uninvestigated dysphagia (this does not apply to the brushings\u002Fbiopsies only portion of the study).\n  * History of eosinophilic esophagitis, achalasia.\n  * Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings\u002Fbiopsies only portion of the study).\n  * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.\n  * Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.\n  * Patients with history of known esophageal or gastric varices or cirrhosis.\n  * Patients with history of surgical esophageal resection for esophageal carcinoma.\n  * Patients with congenital or acquired bleeding diatheses.\n  * Patients with a history of esophageal squamous dysplasia.\n  * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.\n  * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.",{"count":406,"type":21},1550,[56],"This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia\u002Fadenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.",[27,30],[61,411,412,361,30],"Gastroesophageal Reflux","Reflux","2026-01-23",{"date":415,"type":35},"2026-01-26",{"date":417,"type":35},"2021-07-01",{"date":419,"type":21},"2030-07-30",{"name":120,"class":72},9,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":105,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":236},"100378943","esophacap-for-the-detection-of-early-esophageal-carcinoma-100378943","NCT04214119","EsophaCap for the Detection of Early Esophageal Carcinoma","Inclusion Criteria:\n\n* Undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital from 1\u002F2016 to 12\u002F2025\n* Age greater than 18 years\n* Patients must be able to swallow a capsule\n\nExclusion Criteria:\n\n* Patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer\n* Patients who have undergone esophagectomy\n* Patients who have undergone radiation to the chest\n* Patients who are younger than 18\n* Patients with esophageal stents\n* Patients with esophageal strictures disabling passage of the capsule",{"count":429,"type":21},2500,"This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology.",[27,361,362],"2025-12-15",{"date":434,"type":35},"2025-12-16",{"date":436,"type":35},"2016-01-12",{"date":438,"type":21},"2028-12-19",{"name":440,"class":72},"Johns Hopkins University",{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":154,"enrollmentInfo":448,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":121},"100557024","barretts-esophagitis-in-anorexia-nervosa-bingepurge-subtype-100557024","NCT06532734","Barrett's Esophagitis in Anorexia Nervosa Binge\u002FPurge Subtype","Presence of Barrett's Esophagitis in a Cohort of People With Eating Disorders Who Engage in Purging Behaviors: A Pilot Study","Inclusion Criteria:\n\n* Patients diagnosed with an eating disorder diagnosis that includes purging history\n* Ages 18-65\n* Purging history =\\>5 years\n* Purging or rumination at a minimum of once daily upon admission.\n* Admission to the ACUTE Center for Eating Disorders and Severe Malnutrition\n\nExclusion Criteria:\n\n* Any eating disorder diagnosis that does not include purging behaviors\n* Ages under 18 and over 65\n* Patients who otherwise meet the current ACG screening guidelines (chronic GERD and 3 or more risk factors for Barrett's mentioned in the Background)\n* Received mandated care at time of enrollment\n* Inability to consent to participate in the research",{"count":7,"type":21},"To better define the presence of Barrett's esophagus (BE) via non-endoscopic testing in an eating disorder cohort with purging (vomiting\u002Frumination) behaviors",[27,451,452,453,454,30],"Anorexia Nervosa, Binge Eating\u002FPurging Type","Rumination","Vomiting","Eating Disorders","2025-12-03",{"date":457,"type":35},"2025-12-10",{"date":459,"type":35},"2024-11-12",{"date":461,"type":21},"2026-11",{"name":463,"class":72},"Denver Health and Hospital Authority",{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":486},"100497169","surveillance-vs-endoscopic-therapy-for-barretts-esophagus-with-low-grade-dysplasia-100497169","NCT05753748","Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia","A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia (The SURVENT Trial)","SURVENT","Inclusion Criteria: Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND:\n\nMeets all the following criteria will be eligible for enrollment:\n\n1. Male or female, age ≥18 years,\n2. Subject has endoscopic evidence of Barrett's esophagus characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas demonstrating columnar metaplasia with goblet cells. This inclusion criterion will exclude patients with intestinal metaplasia with dysplasia of the gastric cardia,\n3. Biopsies within the previous 12 months demonstrating Barrett's esophagus and low grade dysplasia,\n4. Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained from the referring physician),\n5. Demonstrated ability to tolerate proton pump inhibitor (PPI) therapy based on patient self-report, and, Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures.\n\nExclusion Criteria:\n\n1. Pregnancy;\n2. Prior endoscopic eradication therapy for Barrett's esophagus;\n3. History of high grade dysplasia or post-endoscopy esophageal adenocarcinoma;\n4. History of esophageal resection\u002Fesophagectomy\n5. Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis;\n6. Esophageal strictures precluding passage of the endoscope or treatment catheters - patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy;\n7. Esophageal varices or known portal hypertension; and\n8. Life expectancy of \\\u003C2 years as judged by the site investigator. \\* Presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion. Subjects with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology; those with high grade dysplasia or post-endoscopy esophageal adenocarcinoma pathology will exit the study after a 30-day safety follow up.",{"count":473,"type":21},680,[56],"The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy.\n\nTo diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells.\n\nEndoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments.\n\nWhile both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other.\n\nBarrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and\u002For cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia.\n\nThis is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data.",[59,27,30],[27,30,62],"2025-11-18",{"date":480,"type":35},"2025-11-24",{"date":482,"type":35},"2023-01-24",{"date":484,"type":21},"2029-04-30",{"name":71,"class":72},23,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":105,"sex":17,"minAge":493,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":145},"100568928","multi-site-detection-of-barretts-esophagus-in-patients-without-chronic-gerd-symptoms-100568928","NCT06687603","Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms","Inclusion Criteria:\n\nPatients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be:\n\n* Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:\n* No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:\n* No significant dysphagia or odynophagia; but who do have:\n* Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:\n* Adults \\> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \\> 35 inches for women and \\> 40 inches for men), current smoker or smoking history \\> 10 pack years, white race, male sex, confirmed history of BE\u002FEAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of prior EGD procedure in past ten years\n* Inability to provide written informed consent\n* History of weekly of more frequent heartburn or regurgitation for five or more years\n* On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \\> 1.5\n* Known history of esophageal varices or esophageal stricture\n* Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and\u002For having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and\u002For esophageal ulceration\n* History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills\n* Oropharyngeal tumor\n* History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure","50 Years",{"count":495,"type":21},800,[56],"The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus?\n\nParticipants will:\n\n* Participate in a questionnaire.\n* Undergo a capsule balloon test, called EsoCheck.\n* Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus.\n* Participants will undergo upper endoscopy as part of standard of care.",[27,411,30],[500,501],"Esophagus","Non-endoscopic","2025-11-12",{"date":504,"type":35},"2025-11-13",{"date":506,"type":35},"2025-03-10",{"date":508,"type":21},"2029-09-27",{"name":510,"class":72},"Case Comprehensive Cancer Center",{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":258},"100349514","pilot-study-for-oct-guided-in-vivo-laser-capture-microdissection-for-assessing-the-prognosis-of-barretts-esophagus-100349514","NCT03830801","Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus","IVLCM","Inclusion Criteria:\n\n* Participants must have a current or prior diagnosis of Barrett's Esophagus\n* Participants must be over the age of 18.\n* Participants must be able to give informed consent.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Participants who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.\n* Participants with a history of hemostasis disorders.\n* Participants with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule.\n* Participants with a know history of esophageal varices\n* Participants above 80 years of age",{"count":202,"type":21},[56],"The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.",[27],[61,523,524,525,526,527],"EGD","Endoscopy","Biopsy","Tethered Capsule Endomicroscopy","OCT","2025-10-20",{"date":530,"type":35},"2025-10-22",{"date":532,"type":35},"2017-12-06",{"date":534,"type":21},"2028-12",{"name":536,"class":72},"Massachusetts General Hospital",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":545,"targetDuration":547,"studyType":158,"phases":4,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":258},"100577811","less-is-more-in-barrett-surveillance-care-evaluation-of-barretts-patients-with-low-risk-in-whom-endoscopic-surveillance-is-stopped-the-bliss-project-100577811","NCT06803147","\"Less-is-more in Barrett-surveillance\" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.","\"Less-is-more in Barrett-surveillance\": Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project","BLISS","Inclusion Criteria:\n\nIn order to be eligible to be included in this study, a subject must meet all of the following criteria:\n\n* Histological diagnosis of non-dysplastic Barrett's esophagus (NDBE).\n* Barrett's esophagus segment with a maximum length of less than 5 cm (Prague classification M\\\u003C5).\n* At least one adequate, high-quality upper endoscopy with assessment of the Barrett segment performed according to existing guidelines, as evaluated by the referring endoscopist. A high-quality endoscopy is defined as: adequate imaging with high-resolutoin endoscope with sampling performed according to the Seattle protocol, and in absence of LA grade C or D reflux esophagitis. The endoscopist determines whether the last endoscopy was of high-quality. If this was not the case, the endoscopist may decide to schedule a new encoscopy.\n* No recent history of confirmed indefinite for dysplasia (IND) or confirmed LGD, defined as no LGD and\u002For IND in the last 2 years and not in the last endoscopy.No history of HGD or cancer in BE\n* Age ≥55 years and ≤75 years at the moment of inclusion.\n* Informed consent provided by the patient or legal guardian.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* BE with (history of) dysplasia, either:\n\n  * Prior cancer\n  * Prior HGD\n  * Confirmed LGD or IND in the last 2 years or during the last endoscopy\n* Patients with an endoscopically visible lesion\n* Patients with active reflux esophagitis LA grade C or D\n* Patients with Barrett's esophagus with a maximum extent \\\u003C1cm in length with currently already no surveillance indication.\n* Patients with a family history of esophageal adenocarcinoma, defined as at least one first-degree relative with adenocarcinoma of the esophagus or gastric cardia.",{"count":546,"type":21},3156,"10 Years","Rationale:\n\nUntil recently, the conventional strategy outlined by both national and international guidelines for managing non-dysplastic (ND) Barrett esophagus (BE), involved endoscopic surveillance at 3 to 5 year intervals, aiming to reduce mortality from esophageal adenocarcinoma (EAC) through early detection and treatment. However, scientific evidence that supports the benefits in EAC-specific and\u002For overall survival, or that shows cost-effectiveness, is lacking. This has led to a re-evaluation of surveillance practices, particularly for NDBE patients at low risk of progression to EAC. For this reason, and in light of the 'NVMDL knowledge agenda,' a recent adjustment has been made to the Dutch guideline, recommending discontinuation of endoscopic surveillance for low-risk NDBE patients, hypothesizing that discontinuing endoscopic surveillance in low-risk NDBE patients will not lead to a relevant increase in the incidence of clinically significant EAC. This study aims to evaluate long-term outcomes of this guideline change.\n\nObjective:\n\nThe primary objective is to evaluate the incidence of clinically apparent EAC after discontinuation of endoscopic surveillance in low-risk NDBE patients.\n\nStudy design: This is a nationwide, prospective, single-arm observational study with a minimum duration of 10 years. All patients in the Netherlands, eligible for study participation, will be approached and, upon signing informed consent, included in this care evaluation project. Baseline information will be collected from endoscopy and pathology reports and the electronic patient files. During follow-up, data will be collected from existing registries, including the national pathology database named Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA), the national statistics database named: Central Bureau van Statistiek (CBS), Integraal Kankercentrum Nederland (IKNL), and if necessary, additional information will be collected from electronic patient files in patient's hospital or the general practitioner.\n\nOn an annual basis, study outcomes will be evaluated and reviewed by a DSMB according to pre-defined stopping rules.\n\nStudy population:\n\nAll low-risk NDBE patients in the Netherlands in whom endoscopic surveillance will no longer be indicated based on the new Dutch guideline recommendations will be included. This includes patients with (1) BE with a maximum extent \\\u003C5cm in length; (2) without (a history of) dysplasia; and (3) without a family history for EAC. A family history of EAC is defined as at least one first-degree relative with esophageal cancer.\n\nMain study parameters\u002Fendpoints:\n\nPrimary study endpoint: the annual incidence of patients with clinically apparent EAC during a minimum follow-up of 10 years. Clinically apparent EAC is defined as one of the following:\n\n* EAC related death, and\u002For\n* EAC that exceeds boundaries for curative endoscopic treatment, defined as any symptomatic EAC that undergoes (1) palliative treatment; (2) esophagectomy; (3) chemotherapy; (4) radiotherapy; (5) immunotherapy; and\u002For (6) non-endoscopic therapy otherwise.\n\nTwo separate cohorts will be identified; (1) patients with an endoscopic surveillance history at the moment of study inclusion; and (2) patients with newly diagnosed NDBE at the moment of study inclusion. The primary endpoint will be evaluated separately in both cohorts. The power calculation will be based on the primary endpoint evaluation only in cohort 2, since cohort 1 is prone to selection bias.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nThis registry that evaluates outcomes of regular clinical care, imposes minimal burden on participants. Subjects are not exposed to procedures or interventions. Data collection is based on existing national databases and medical records. Participants will provide informed consent for inclusion in the database, to ensure that patients understand the study's scope and their rights, with no further obligations for active involvement. Of note, discontinuation of endoscopic surveillance is standard practice according to the guideline. The current studies passively evaluates the outcomes, and patients only provide informed consent for inclusion in the registry. If a patient does not sign the informed consent form, the patient is not included in the registry, still, endoscopic surveillance for this patient will be discontinued.\n\nAlso robust measures will be implemented to ensure strict adherence to data protection regulations and safeguard participants' privacy and confidentiality. The primary focus remains on upholding ethical standards and minimizing any potential risks to participants while still be able to monitor relevant outcomes",[27,319],[27,551,552,553],"Esophageal cancer","Appropriate care","Endoscopic surveillance","2025-09-30",{"date":556,"type":35},"2025-10-03",{"date":558,"type":35},"2025-03-01",{"date":560,"type":21},"2038-02-07",{"name":562,"class":72},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":258},"100571467","ultralong-segment-barretts-esophagus-towards-a-capsule-sponge-surveillance-strategy-100571467","NCT06720636","Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy","ULSBE","Inclusion Criteria:\n\n* Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Individuals with a diagnosis of an oro-pharynx, esophageal or gastro-esophageal tumor (T2 staging and above), or symptoms of dysphagia\n* Esophageal varices or stricture requiring dilatation of the esophagus\n* Individuals who have had a cerebrovascular event \\\u003C 6 months prior where their swallowing has been affected\n* Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation (RFA) or Argon Plasma Coagulation (APC) for dysplastic Barrett's esophagus\n* Participants who are unable to provide informed consent\n* Participants under age 18 years",{"count":571,"type":21},137,[56],"The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.",[27],"2025-08-06",{"date":577,"type":35},"2025-08-12",{"date":579,"type":35},"2025-02-03",{"date":581,"type":21},"2027-09",{"name":583,"class":72},"Erasmus Medical Center",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":105,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":591,"targetDuration":593,"studyType":158,"phases":4,"briefSummary":594,"conditions":595,"keywords":626,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":258},"100474891","inadvance-surveillance-prevention-and-interception-in-a-population-at-risk-for-cancer-100474891","NCT05463796","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer","Inclusion Criteria:\n\n* Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):\n\n  1-Hereditary risk for cancer including\n  * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes\n  * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing)\n  * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)\n  * Hereditary Cancer Prediction Model-based elevated cancer risk\n  * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\\&N cancer for example), etc.\n* Exposed High Risk including\n\n  * Childhood cancer survivors with treatment exposures associated with increased risk of cancer\n  * Adult cancer survivors with treatment exposures associated with increased risk of cancer\n  * Documented high level exposure to group 1 IARC carcinogens\n  * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \\>50, Smoking history of \\>15 pack years, First-degree relative history of lung cancer or COPD\n  * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis\n* Precursor Lesions including\n\n  * Breast: ductal\u002Flobular carcinoma in situ (CIS) and atypical hyperplasia\n  * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia\u002Fadenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis\n  * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia\u002Fcarcinoma in situ,\n  * Lung: Adenomatous hyperplasia\n  * H\\&N: high-risk oral precancerous diseases\n  * Skin: Class II melanocytic lesions. Squamous dysplasia\n  * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas\n  * Thoracic: Lung nodules detected on screening CT that prompt further follow-up\n  * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia\n  * Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.\n* FAMILY MEMBERS or healthy individuals\n\nExclusion Criteria:\n\nThere are no exclusion criteria for the study.\n\nNote: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.",{"count":592,"type":21},5000,"20 Years","This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer.\n\n* The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.\n* The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.",[596,597,598,599,600,601,602,603,604,27,605,606,607,608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625],"Cancer Risk","Cancer Predisposition Syndrome","Hereditary Cancer Prediction","Childhood Cancer Survivors","Adult Cancer Survivors","IARC Carcinogens","Smoking History","Lung Cancer","Ductal\u002FLobular Carcinoma","Pancreatic Precursor Lesions","Colonic Dysplasia\u002FAdenomata","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Steatohepatitis","Cirrhosis","High Grade Prostatic Epithelial Neoplasia","High-grade Bladder Urothelial Dysplasia\u002FCarcinoma in Situ","Adenomatous Hyperplasia","High-risk Oral Precancerous Diseases","Melanocytic Lesion, Adult","Hematologic Malignancy","Lung; Node","Serous Tubal Intraepithelial Carcinoma","Endometrial Intraepithelial Neoplasia","Cervical and Endocervical Carcinoma in Situ","Vulvar Intraepithelial Neoplasia","Nephrogenic Rests","Benign Bone Lesions With Risk of Malignant Degeneration","Giant Cell Tumor","Osteochondroma","Spitz Nevus",[627,628,629,630],"Hereditary Risk for Cancer","Childhood cancer survivors","Adult cancer survivors","Precursor Lesions","2025-08-04",{"date":633,"type":35},"2025-08-07",{"date":635,"type":35},"2023-04-25",{"date":637,"type":21},"2032-03-25",{"name":639,"class":72},"Dana-Farber Cancer Institute",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":17,"minAge":647,"maxAge":106,"enrollmentInfo":648,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":657,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":258},"100573464","nonendoscopic-screening-for-barretts-esophagus-in-veterans-without-chronic-reflux-100573464","NCT06746623","Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux","Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux","Inclusion Criteria:\n\n* Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.\n\n  1. Adults \\> 40 and \\\u003C 85 years old who have no prior EGD and can provide informed consent\n  2. Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:\n\n     a. Meet ACG\u002FAGA Clinical Guideline criteria for BE screening. Eligible subjects will have at least three additional risk factors for BE (white race, obesity defined as BMI \\> 30, male gender, current smoker or smoking history \\> 10 pack years, family history of Barrett's esophagus or EAC central obesity (waist size \\> 35 inches for women and \\> 40 inches for men), white race, male sex, confirmed history of BE\u002FEAC in at least two family members, with one a first degree relative).\n  3. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:\n  4. No significant dysphagia or odynophagia\n\nExclusion Criteria:\n\n* Exclusion Criteria\n\n  1. History of prior EGD procedure in past ten years\n  2. Inability to provide written informed consent\n  3. History of weekly or more frequent heartburn or regurgitation for five or more years\n  4. On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \\> 1.5\n  5. Known history of esophageal varices or esophageal stricture\n  6. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and\u002For having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and\u002For esophageal ulceration\n  7. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills\n  8. Oropharyngeal tumor\n  9. History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \\\u003C4%)\n  10. History of myocardial infarction or cerebrovascular accident within past 6 months","40 Years",{"count":649,"type":21},400,[56],"The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.",[653,654,655,656,27],"Obese Patients","Tobacco Use","Veterans","Family History of Esophageal Cancer",[658,659,324],"Non-endoscopic screening","esophagus","2025-06-03",{"date":662,"type":35},"2025-06-05",{"date":664,"type":35},"2025-04-11",{"date":666,"type":21},"2028-12-31",{"name":668,"class":669},"Louis Stokes VA Medical Center","FED"]