[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622077":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":12,"responsibleParty":31,"collaborators":12,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":12,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":55,"overallStatus":60,"whyStopped":12,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":12},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard care arm","NO_INTERVENTION","Surveillance colonoscopy performed at third year after initial colonoscopy",null,{"label":14,"type":15,"description":16,"interventionNames":17},"FIT arm","EXPERIMENTAL","Intervention: Early triage using Fecal immunochemical test\n\nDetailed: Participants in this group will undergo Fecal Immunochemical Testing (FIT) in the first and second years (FIT 1 \\& 2) following their initial colonoscopy. If FIT 1 is positive, a colonoscopy will be scheduled within three months; regardless of those findings, a surveillance colonoscopy is still required in the third year. If FIT 1 is negative, the patient proceeds to FIT 2 in the second year. A positive FIT 2 likewise triggers a colonoscopy within three months, and a third-year surveillance colonoscopy remains mandatory unless the FIT 2-triggered colonoscopy occurs between 2.5 and 3.5 years after the initial procedure, in which case it fulfills the third-year requirement. If both FIT 1 and FIT 2 are negative, the participant will undergo their scheduled surveillance colonoscopy in the third year.",[18],"Diagnostic Test: Early triage using Fecal immunochemical test",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIAGNOSTIC_TEST","Early triage using Fecal immunochemical test","Fecal immunochemical test would be provided at first and second year after initial colonoscopy in FIT arm. Those with positive results would be arranged with early surveillance colonoscopy",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Wei-Yuan Chang, MS","CONTACT","+886-917-223-272","wychang1005@gmail.com",{"type":32,"investigatorFullName":33,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","National Taiwan University Clinical Trial Center","100622077","ultra-high-risk-surveillance-to-avoid-future-events-the-ultra-safe-trial-100622077",false,"NCT07378930","ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial","ULTRA-SAFE","Inclusion Criteria:\n\n1. Age: Adults aged 40 to 75 years.\n2. Initial Colonoscopy Findings: Detection and removal of at least two advanced adenomas during the baseline colonoscopy.\n3. Adherence: Willingness to comply with the assigned screening protocol, including fecal immunochemical testing (FIT) and follow-up colonoscopies\n\nExclusion Criteria:\n\n1. Age: Individuals younger than 40 or older than 75 years.\n2. High-Risk Predispositions: Patients with inflammatory bowel disease (IBD), Familial Adenomatous Polyposis (FAP), or a documented hereditary colorectal cancer syndrome (e.g., Lynch syndrome).\n3. Cancer History: A history of colorectal cancer (excluding carcinoma in situ).\n4. Contraindications: Patients for whom polypectomy is clinically inappropriate or unsafe.\n5. Adenoma Count\u002FType: Failure to meet the requirement of at least two advanced adenomas during the initial colonoscopy.\n\n7.Extensive Low-Risk Lesions: Presence of more than ten low-risk adenomas.\n\n8.Pregnancy: Currently pregnant individuals.","ALL","40 Years","75 Years",{"count":45,"type":46},940,"ESTIMATED","INTERVENTIONAL",[49],"NA","The ULTRA-SAFE clinical trial is a prospective, randomized study designed to address the limitations of current \"one-size-fits-all\" colorectal cancer surveillance guidelines. While international standards recommend a three-year follow-up colonoscopy for all high-risk patients, data suggests that those with multiple advanced adenomas face a significantly higher recurrence risk (20%) compared to those with only low-risk adenomas (9%). To provide more personalized care, the trial compares a Standard Arm (colonoscopy at year three) against a FIT Arm, where participants undergo annual fecal immunochemical testing in years one and two. A positive FIT triggers an earlier colonoscopy, with the goal of reducing the 3-year prevalence of metachronous advanced colorectal neoplasms (meta-ACRN) from 20% to approximately 12.7%. The study has enrolled roughly 940 participants to statistically validate whether this early screening intervention can effectively prevent future malignant events in ultra-high-risk populations.",[52,53,54],"Colorectal Neoplasms","Colorectal Cancer Prevention","Surveillance Colonoscopy",[56,57,58,59],"Colonoscopy surveillance","Colorectal cancer prevention","Post-polypectomy surveillance","Fecal immunochemical test","NOT_YET_RECRUITING","2026-01-23",{"date":63,"type":64},"2026-01-30","ACTUAL",{"date":66,"type":46},"2026-03-01",{"date":68,"type":46},"2031-05-01",{"name":5,"class":6}]