[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premalignant-lesion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premalignant-lesion":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,68,91,122],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100497880","application-of-artificial-intelligence-on-the-diagnosis-of-helicobacter-pylori-infection-and-premalignant-gastric-lesion-100497880",false,"NCT05762991","Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion","Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age 20-80\n2. Scheduled endoscopy\n\nExclusion Criteria:\n\n1\\. History of gastric surgery","ALL","20 Years","80 Years",{"count":20,"type":21},6000,"ESTIMATED","OBSERVATIONAL","The aim of this study is to evaluate the impact of artificial intelligence (AI) assistance during routine upper endoscopy on gastric cancer-specific mortality. We hypothesize that AI-assisted endoscopic interpretation can further reduce gastric cancer-related mortality through two mechanisms: (1) improved detection of H. pylori infection, facilitating timely eradication therapy and subsequent prevention of gastric carcinogenesis; and (2) earlier identification of premalignant gastric conditions, enabling appropriate surveillance endoscopy and earlier detection of gastric cancer. The primary endpoint is gastric cancer-specific mortality.",[25,26],"Helicobacter Pylori Infection","Premalignant Lesion","RECRUITING","2026-06-21",{"date":30,"type":31},"2026-06-24","ACTUAL",{"date":33,"type":31},"2021-12-24",{"date":35,"type":21},"2028-12-31",{"name":37,"class":38},"National Taiwan University Hospital","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100637944","ai-based-risk-prediction-model-for-upper-digestive-tract-cancer-100637944","NCT07605312","AI-Based Risk Prediction Model for Upper Digestive Tract Cancer","Development of Artificial Intelligence Risk Prediction Model for Upper Digestive Tract Cancer Using High Resolution Endoscopic Image, Digital Pathology, Genetics, and Oro-gastro-intestinal Microbiota.","Inclusion Criteria:\n\n* Patients undergoing upper gastrointestinal endoscopy.\n* Patients with at least one of the following conditions or indications:\n\n  * Previous or current Helicobacter pylori infection (confirmed by serology, histopathology, urea breath test, rapid urease test, or stool antigen test);\n  * Dyspeptic symptoms;\n  * Gastroesophageal reflux disease;\n  * History of oral, oropharyngeal, or hypopharyngeal squamous cell carcinoma;\n  * Barrett's esophagus;\n  * Gastric premalignant lesions (intestinal metaplasia or atrophic gastritis);\n  * Gastric subepithelial lesions.\n\nExclusion Criteria:\n\n\\-",true,"40 Years",{"count":50,"type":21},10000,"10 Years","Upper digestive tract cancers are often preceded by pre-malignant lesions, but there is limited evidence regarding optimal risk prediction models and screening strategies for disease progression and cancer development. This prospective multicenter cohort study aims to establish a longitudinal database integrating clinical information, endoscopic findings, pathology, genetics, epigenetics, and gastrointestinal microbiota data from subjects undergoing upper digestive tract endoscopy.\n\nThe study will develop explainable artificial intelligence (AI)-based risk prediction models to identify factors associated with disease progression, treatment response, and cancer development. Participants will be followed longitudinally to evaluate changes in lesion severity and clinical outcomes.",[54,26,55,56,57,58],"Gastric Cancer (GC)","Gastric Intestinal Metaplasia","Atrophic Gastritis","Dysplasia Stomach","Esophageal Cancer (EsC)","NOT_YET_RECRUITING","2026-05-25",{"date":62,"type":31},"2026-05-28",{"date":64,"type":21},"2026-05-18",{"date":66,"type":21},"2030-05-18",{"name":37,"class":38},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":39},"100559204","phase-2-phase-ii-randomized-placebo--controlled-study-of-intralesional-nivolumab-for-high-risk-oral-premalignant-lesions-100559204","NCT06561087","Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions","Inclusion Criteria:\n\n1. Presence of a treatment naïve, biopsy proven, intraoral premalignant lesion visible from oral cavity.\n2. Be willing and able to provide written informed consent for the trial. In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC \"Policy For Consenting Non-English Speaking Participants.\"\n3. Be \\>\u002F= 18 years of age on day of signing informed consent.\n4. Be willing to provide tissue, either archive or from a newly obtained oral biopsy.\n5. Have a performance status of 0-2 on the ECOG Performance Scale.\n6. Demonstrate adequate organ function as defined in Table 1\n7. Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n8. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of study therapy through 120 days after the last dose of Nivolumab. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n\nExclusion Criteria:\n\n1. Is currently participating and receiving study therapy with potential anti-neoplastic activity or has participated in a study of an investigational agent and received study therapy with potential anti-neoplastic activity within 4 weeks of the first dose of treatment.\n2. Has a known history of active TB (Bacillus Tuberculosis)\n3. Hypersensitivity to nivolumab or any of its excipients.\n4. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 2 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n5. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 2 or at baseline) from adverse events due to a previously administered agent.\n6. Has a known additional malignancy that is progressing or requires active treatment other than adjuvant hormonal therapy. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ cervical cancer.\n7. Has known history of, or any evidence of active, non-infectious pneumonitis.\n8. Has an active infection requiring systemic therapy.\n9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n10. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n11. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of treatment with nivolumab, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n12. Has received a live vaccine within 30 days of planned start of study therapy.\n\nNote: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.","18 Years",{"count":76,"type":21},45,"INTERVENTIONAL",[79],"PHASE2","To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions",[26],"2026-02-26",{"date":84,"type":31},"2026-03-02",{"date":86,"type":31},"2025-02-27",{"date":88,"type":21},"2029-05-30",{"name":90,"class":38},"M.D. Anderson Cancer Center",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":39},"100597275","adaptive-anastomosis-for-anterior-resection-in-sigmoid-and-proximal-rectal-cancer-or-premalignant-lesions-100597275","NCT07056374","Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions","Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesion: a Multicentre Non-randomised Clinical Effectiveness Trial )ADAPT","ADAPT","Inclusion Criteria:\n\n* Biopsy proven cancer of the sigmoid colon or proximal rectum (cT1-4aN0-2M0) that require AR as the procedure of choice or premalignant lesions not amenable to endoscopic resection, that require AR as the procedure of choice.\n* Suitable for curative AR\n* Suitable for elective laparoscopic or robotic surgery\n* Cognitive ability to take part in the study, to understand the information the patient receives about participating in the study, to provide informed consent and to agree to complete the questionnaires.\n\nExclusion Criteria:\n\n* Pre-existing health conditions requiring emergency surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia.\n* Cancer with distant metastases (TNM Stage IV).\n* Intestinal or anal stenosis or other obstructions distal to the planned anastomosis.\n* Prior pelvic radiation including neoadjuvant chemoradiotherapy.\n* Contraindications to general anaesthesia.\n* Need for defunctioning ileostomy (intention to treat).\n* Patients who have a contra-indication for or are unable to receive preoperative bowel preparation or at least two enemas prior to surgery.\n* Immunocompromised patients e.g. taking steroids or receiving immunotherapy.\n* Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection (e.g. diverticulitis) which may impair the use of C-REX RectoAid Cath",{"count":100,"type":21},165,"Background: Anastomotic leakage (AL) after colorectal surgery remains a significant challenge, associated with increased morbidity, mortality, poor oncological outcomes, and reduced quality of life. Despite surgical advances, AL rates for colorectal procedures continue to range from 3% to 25%, especially in distal anastomoses.\n\nThe commonly used cross-stapled circular anastomosis for anterior resections (AR) activates a foreign body response delaying gastrointestinal wound healing and potentially increasing the risk of AL. Additionally, crossed stapler lines further increase the risk of AL. An adaptive anastomosis technique eliminates permanent foreign body material, thereby reducing negative effects on wound healing and avoiding cross-stapling potentially lowering the incidence of AL. These areas have shown to have a lower burst pressure compared to a single stapled anastomosis.\n\nAn adaptive anastomotic technique eliminates cross-stapling and permanent foreign body material in the anastomosis reducing the negative effects on wound healing potentially lowering the incidence of AL.\n\nDesign: This is a prospective, international, non-randomized, multicentre study.\n\nEndpoints: The Primary objective of this trial is to assess the incidence of AL within 30 days after surgery. Secondary objectives are to assess anastomotic integrity at 90 days and 1 year, intraoperative efficacy and efficiency of the C-REX device, time to evacuation of the anastomotic ring, mode of evacuation and related patient experience, postoperative morbidity and readmissions, C-reactive protein (CRP) profile in the early postoperative period, functional outcomes, cost-effectiveness and surgical quality.\n\nPopulation: A total of 165 patients (age ≥ 18 years) with histologically proven cT1-4aN0-2M0 cancer of the sigmoid colon or proximal rectum, or premalignant lesions not amenable to endoscopic resection, that require elective AR will be enrolled throughout 10 European colorectal centers.\n\nStudy procedures: The anastomosis will be created using the C-REX RectoAid Cath. The healing period will be approximately 10 days. The anastomotic ring detaches via necrosis and is evacuated with the feces. Patients will be asked to fill out questionnaires regarding Low Anterior Resection Syndrome (LARS) and use of healthcare and these will be gathered preoperatively, 90 days postoperative and 1 year after surgery. At 12 months a CT-scan and colonoscopy will be performed.",[103,104,26,105],"Rectal Cancer","Sigmoid Cancer","Colorectal Cancer",[107,108,109,110,111,112],"Anterior Resection","Adaptive anastomosis","Compression anastomosis","Anastomotic Leakage","Sigmoid resection","Partial Mesorectal Excision","2025-07-08",{"date":115,"type":31},"2025-07-09",{"date":117,"type":31},"2025-03-25",{"date":119,"type":21},"2027-09-01",{"name":121,"class":38},"Amsterdam UMC, location VUmc",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":47,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":39},"100473931","detection-of-oral-and-throat-cancers-using-oralviome-cancer-testing-system-100473931","NCT05451303","Detection of Oral and Throat Cancers Using OralViome Cancer Testing System","Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis","Inclusion Criteria\n\n* Signed Informed Consent obtained\n* 18 years and older\n* At a high risk of developing oral or throat cancer based on clinician's discretion\n\nExclusion Criteria\n\n* Pregnancy\n* Use of fertility enhancing medications",{"count":130,"type":21},475,"To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.",[133,134,26],"Oral Squamous Cell Carcinoma","Oropharynx Squamous Cell Carcinoma",[136,137,138,139,140,141,142,143,144,145],"Viome","oral cancer","detection","OSCC","OPMD-B","OPMD-PM","OPMD","OPV","Tobacco","HPV","2025-01-27",{"date":148,"type":31},"2025-01-29",{"date":150,"type":31},"2022-05-27",{"date":152,"type":21},"2026-12",{"name":136,"class":154},"INDUSTRY"]