[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637201":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":31,"responsibleParty":47,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":11,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"S-Adenosylmethionine (SAMe)","EXPERIMENTAL",null,[13],"Drug: S-Adenosylmethionine (SAMe)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","S-Adenosylmethionine (SAMe) will be given at an oral daily dose of 1600-2400 mg daily divided into 400 mg tablets in the morning before breakfast and in the evening before dinner to constitute the total daily dose.",[9],[20],{"name":21,"affiliation":5,"role":22},"Jun Gong, MD","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Clinical Trial Recruitment","CONTACT","310-423-3713","GroupCancerTrialInformation@cshs.org",{"name":21,"role":26,"phone":11,"phoneExt":11,"email":30},"jun.gong@csmc.edu",[32],{"facility":5,"status":11,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Los Angeles","California","90048","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-118.24368,34.05223,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":27,"phoneExt":11,"email":28},"Clinical Trial Recruitment Navigator",{"type":48,"investigatorFullName":21,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Sponsor-Investigator","100637201","phase-1-a-phase-i-trial-of-s-adenosylmethionine-same-for-chemoprevention-of-colorectal-adenomas-100637201",false,"NCT07582003","A Phase I Trial of S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas","Inclusion Criteria:\n\n1\\) Adults ≥18 years old with histologically confirmed, curatively resected stage I-II colorectal cancer; 2) must agree to pre-intervention (baseline) stool sample and distal colon biopsy; 3) must start study intervention within 30 days ±7 days of the baseline biopsy; 4) must be able to complete up to 12 months of intervention prior to planned postoperative surveillance colonoscopy within 1 year of surgery; 5) must undergo repeat stool sample and distal colon biopsy within 7 days ±4 days of the last dose of study intervention; 6) did not receive adjuvant therapy; 7) not currently breastfeeding or pregnant.\n\nExclusion Criteria:\n\n1\\) Have a history familial adenomatous polyposis (FAP); 2) have a history of hereditary nonpolyposis colorectal cancer; 3) history of inflammatory bowel disease; 4) high-dose aspirin (except for low-dose (≤100 mg\u002Fday) aspirin for cardiovascular prevention) within the past 60 days of enrollment.","ALL","18 Years",{"count":59,"type":60},18,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","This study will enroll a total of 18 patients who have undergone curative surgery for stage I or II colorectal cancer and are planned for post-surgical surveillance without any need for chemotherapy at Cedars-Sinai Medical Center. All subjects will receive an oral daily supplement called S-Adenosylmethionine (SAMe) which has been hypothesized to reduce colorectal polyps (precursors to colorectal cancer) and prevent colorectal cancer formation. The study investigates what the appropriate dosage of SAMe is so that there is the lowest risk of side effects, and whether the supplement will prevent polyp formation in a population of patients who at risk for developing polyps and colorectal cancer. The primary endpoint will be to determine the recommended phase II dose (RP2D), the highest safe dose of SAMe that could be studied in larger clinical trials to advance this agent further in clinical development. Secondary endpoints include safety, the rate of postoperative adenomas detected on surveillance colonoscopy, and the effects of SAMe on the colon, specifically, its impact on gut bacteria and tissue markers before and after SAMe treatment to better understand the mechanisms to how SAMe may have its colorectal cancer preventive effects.",[66,67],"Colorectal Cancer (Diagnosis)","Adenoma",[67,69,9],"Colorectal Cancer","NOT_YET_RECRUITING","2026-05-06",{"date":73,"type":74},"2026-05-12","ACTUAL",{"date":76,"type":60},"2026-06-01",{"date":78,"type":60},"2028-06-01",{"name":21,"class":6},1]