[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"barrett-esophagus-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:barrett-esophagus-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100643087","phase-1-development-of-fluorescent-lectin-tracers-with-dedicated-technology-for-in-vivo-detection-of-esophageal-dysplasia-in-barrett-patients-100643087",false,"NCT07643727","Development of Fluorescent Lectin Tracers With Dedicated Technology for in Vivo Detection of Esophageal Dysplasia in Barrett Patients","Glycan Near-Infrared Imaging Using Fluorescently Labeled Wheat Germ Agglutinin (WGA): Evaluation of Safety and Feasibility in a Prospective Pilot Study","GRAIN","Inclusion Criteria:\n\n* Patients with confirmed Barrett's esophagus, esophageal dysplasia, or superficial esophageal ade-nocarcinoma.\n* Patients scheduled for gastroscopy procedure within the UMCG.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to wheat.\n* Celiac disease.\n* Dermatitis herpetiformis.\n* Pregnancy or breastfeeding.","ALL","18 Years",{"count":20,"type":21},49,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to evaluate the feasibility of WGA-800CW with dedicated imaging systems for detection of invisible esophageal dysplasia in patients with Barrett's esophagus.\n\nThe main questions it aims to answer are:\n\n* What is the optimal dose of WGA-800CW that maximizes the tumor-to-background ratio and enables clear visualization of the tumor?\n* Can fluorescence endoscopy with WGA-800CW in combination with qFME detect dysplastic esophageal lesions?\n\nIn this non-randomized, non-blinded, prospective, feasibility intervention study, 49 participants with Barrett's esophagus will be included. Patients will undergo the combined procedure (qFME and\u002For OCT-NIRF and HD-WLE). WGA-800CW will be topically administered via a spray catheter during gastroscopy procedures and fluorescent signal will be assessed with qFME and\u002For OCT-NIRF.",[27,28],"Barrett's Esophagus With or Without Dysplasia","Barrett Esophagus Adenocarcinoma",[30,31,32,33,34,35],"Glycan","Oncology","Fluorescent tracers","qFME","First-in-human","Lectin","NOT_YET_RECRUITING","2026-06-08",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":21},"2026-06-01",{"date":44,"type":21},"2028-10-31",{"name":46,"class":47},"University Medical Center Groningen","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"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":58,"type":21},266,[60],"NA","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.",[63,28,64,65,66],"Barrett Esophagus","Adenocarcinoma - GEJ","Gastroenterology","Gastroenterological Cancer",[63,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"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":85,"type":40},"2026-03-06",{"date":42,"type":21},{"date":88,"type":21},"2030-12-31",{"name":90,"class":47},"University Hospital, Antwerp",10,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":100,"targetDuration":102,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":48},"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":101,"type":21},3156,"10 Years","OBSERVATIONAL","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",[63,28],[63,107,108,109],"Esophageal cancer","Appropriate care","Endoscopic surveillance","RECRUITING","2025-09-30",{"date":113,"type":40},"2025-10-03",{"date":115,"type":40},"2025-03-01",{"date":117,"type":21},"2038-02-07",{"name":119,"class":47},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]