[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"San Raffaele University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":170},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,80,107,141],{"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":4,"briefSummary":23,"conditions":24,"keywords":47,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100570529","lynch-syndrome-x-talk-of-enteral-mucosa-with-immune-system-100570529",false,"NCT06708429","Lynch Syndrome X-Talk of Enteral Mucosa With Immune System","Impact of Immune-surveillance on the Development of Colorectal Cancer in Patients With Lynch Syndrome","LYNX-EYE","Inclusion Criteria (for participants with Lynch syndrome):\n\n* Age ≥18 years\n* All sexes eligible\n* Established diagnosis of Lynch syndrome performed as part of clinical practice, with a germline pathogenic\u002Flikely pathogenic variant in one of the following genes: MLH1, MSH2, MSH6, PMS2, and EpCAM\n* Subjects with Lynch syndrome undergoing surveillance gastrointestinal endoscopy and\u002For surgery according to clinical practice\n* Fertile patients (both males and females) are eligible\n* Lactating women are eligible\n\nInclusion Criteria (for participants without Lynch syndrome):\n\n* Age ≥18 years\n* All sexes eligible\n* Patients with sporadic colorectal lesions, including colorectal cancer and colorectal adenomas\n* Healthy controls without colorectal cancer or adenomas undergoing lower gastrointestinal endoscopy for abdominal pain\n* PREMM5 \\\u003C 2.5 \\[PREMM5 is an online, free-to-use, clinical prediction algorithm that estimates the cumulative probability of an individual carrying a germline mutation in the mismatch repair genes responsible for Lynch syndrome\\].\n\nExclusion Criteria (for participants with or without Lynch syndrome):\n\n* Age \\\u003C 18 years;\n* Diseases that are known to predispose to colorectal cancer (personal past or recent history of inflammatory bowel disease);\n* Patients unable\u002Funwilling to provide consent;\n* Pregnancy","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","Lynch syndrome (OMIM #120435) is the most common dominantly inherited colorectal cancer syndrome with an estimated prevalence of 1:270 individuals. It increases the lifetime risk of colorectal and endometrial cancer primarily, but it is associated with a high risk of other cancers (pancreas, stomach, ovarian, central nervous system, skin, among others). It is caused by a germline mutation in one of four DNA mismatch repair genes or a terminal deletion of the MSH2-adjacent gene EpCAM.\n\nDespite adherence to cancer surveillance programs, many patients still develop colorectal cancer and endometrial cancer. The Prospective Lynch Syndrome Database (PLSD) suggests that more frequent surveillance intervals do not significantly improve cancer risk reduction. The PLSD also revealed that the incidence of colorectal cancer in MLH1 and MSH2 carriers was even higher than previously expected, reaching as high as 41-36% among MLH1 carriers, regardless of ethnic background. The development of colorectal cancer despite surveillance is an unresolved question. Therefore, there is an unmet need for effective cancer prevention strategies.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Lynch Syndrome","Lynch Syndrome I","Lynch Syndrome II","Lynch Syndrome I (Site-specific Colonic Cancer)","HNPCC","HNPCC Gene Mutation","Hereditary Cancer Syndrome","Hereditary Cancer","MLH1 Gene Mutation","MLH1 Gene Deletion+Duplication","MLH1 Loss of Expression","MLH1 Gene Inactivation","MSH2 Gene Mutation","MSH2 Gene Deletion+Duplication","MSH2 Loss of Expression","MSH2 Gene Inactivation","MSH6 Gene Mutation","MSH6 Loss of Expression","MSH6 Gene Inactivation","PMS2 Gene Mutation","PMS2 Gene Inactivation","PMS2 Loss of Expression",[48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"Colorectal cancer","Endometrial cancer","Lynch syndrome-associated cancer","Surveillance","Cancer surveillance","Immune profile","Immune escape","Mismatch repair deficiency","Microbiota","Liquid biopsy","MicroRNA","Transcriptomic","Frame shift peptides","MLH1","MSH2","EpCAM","MSH6","PMS2","Hair matrix","RECRUITING","2026-04-21",{"date":70,"type":71},"2026-04-24","ACTUAL",{"date":73,"type":71},"2023-06-01",{"date":75,"type":21},"2034-06-01",{"name":77,"class":78},"San Raffaele University","OTHER",5,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100493350","videocapsule-endoscopy-in-lynch-syndrome-100493350","NCT05704010","Videocapsule Endoscopy in Lynch Syndrome","Role of Videocapsule Endoscopy in Lynch Syndrome: a Multicenter Italian Registry Study","Inclusion Criteria:\n\n* Pathogenic germline variant in one of the MMR genes (MLH1, MSH2\u002FEpcam, MSH6, or PMS2).\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Patients unwilling or unable to provide informed consent\n* Patients with prior small bowel surgery\n* Patients with a contraindication to VCE",true,{"count":89,"type":21},100,"INTERVENTIONAL",[92],"NA","Background Lynch syndrome is caused by a pathogenic variant in one of the four Mismatch Repair genes (MMR): MLH1, MSH2\u002FEpcam, MSH6, or PMS2. These pathogenic variants confer a higher risk of developing colorectal and other cancers, including small bowel cancer. The risk of developing a small bowel adenocarcinoma is about 100 times higher compared to individuals without Lynch syndrome, and the lifetime risk of small bowel cancer is estimated at 4,2%.\n\nThe diagnosis of a small bowel cancer depends on videocapsule endoscopy (VCE). This device is swalled so that it can record images of the small bowel, which are then stored on a wearable device for about 8 hours. The capsule is then expelled in the feces while the images are transferred to a computer to be analysed. To date, there is conflicting evidence on the efficacy of small bowel cancer screening with VCE\n\nRationale: this registry study will collect prospective data from patients with LS undergoing VCE\n\nAim: evaluate the incidence of neoplastic and pre-neoplastic lesions in patients with LS during a VCE-based small bowel cancer screening study\n\nDesign: this is a multicentric, observational study that analyzes data from diagnostic techniques already approved. Patients will not undergo diagnostic procedures beyond what would be recommended by clinical practice.",[25,26,27,33,37,41,44,95],"Small Bowel Adenocarcinoma",[97,98],"Videocapsule","Small bowel",{"date":100,"type":71},"2026-04-22",{"date":102,"type":71},"2018-11-01",{"date":104,"type":21},"2029-12-31",{"name":77,"class":78},1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":116,"targetDuration":118,"studyType":22,"phases":4,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100495547","exogenous-and-endogenous-risk-factors-for-early-onset-colorectal-cancer-100495547","NCT05732623","Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer","Diet obEsity sMoking Epigenetics geneTics biomaRkers Physical Activity: An International Multicenter Case-control Study on Endogenous and Exogenous Risk Factors in Early-onset Colorectal Cancer","DEMETRA","Inclusion Criteria:\n\n* All sexes eligible\n* (for Cases) eoCRC diagnosed between 18 and 49 years and confirmed by histology (biopsy or surgical specimen in case of surgery)\n* (for Controls) negative past and present history of cancer; negative fecal occult blood test (FOBT), or negative colonoscopy.\n\nExclusion Criteria:\n\n* CRC diagnosed at ≥ 50 years\n* Diseases that can modify the dietary regimen (celiac disease, diabetes)\n* Diseases that are known to predispose to eoCRC (personal past or recent history of inflammatory bowel disease, past history of pelvic irradiation)\n* Unable to give written consents and to fill in the electronic questionnaire","49 Years",{"count":117,"type":21},2300,"10 Years","An increase in early-onset colorectal cancers (eoCRC), defined as a CRC before 50 years, is confirmed globally.\n\nCRC pathogenesis has been associated with several risk factors (family history, germline pathogenic variants, obesity, alcohol, physical activity, red meat, and a Western diet).\n\nDesign: an international, multicenter, retrospective case-control study of prospectively enrolled patients; low-risk intervention study as it will perform a fecal occult blood test Endpoint: predictive power of a semi-quantitative food frequency questionnaire (SQFFQ) developed for eoCRC.\n\nCases: Patients with a recent diagnosis of eoCRC (within 2 years from enrollment).\n\nControls: matched by age (matching range ± 5 years) and sex. Healthy volunteers will be mainly enrolled among workers within the participating hospital center. The enrolled healthy volunteers will perform a fecal occult blood test.\n\nVariables of interest: age, sex, ethnicity, BMI at the time of eoCRC diagnosis and at 18 years old, country, tobacco smoking at the time of eoCRC diagnosis and at 18 years old, sitting time, TV-viewing time, moderate-to-vigorous physical activity (MVPA), waist circumference (cm), home blood pressure levels (mmHg), fasting blood glucose (mg\u002Fdl), regular consumption of aspirin\u002FNSAID, calcium and folate supplements, oral contraceptive agents, post-menopausal hormones and years of consumptions, if the filled questionnaire reflects diet for the last 5-10 years before.\n\nCases only: date of eoCRC diagnosis, symptoms at diagnosis, eoCRC localization, eoCRC stage, histological diagnosis, type of surgery, and date (if performed), chemotherapy and radiotherapy (if performed), vital status and duration of follow-up, family history of CRC and other cancers (uterus, ovary, stomach, small intestine, urinary tract\u002Fbladder\u002Fkidney, bile ducts, brain, pancreas, skin tumors), type of germline pathogenetic variant (if performed).\n\nBefore the case-control study, three non-consecutive 24-hour Dietary Recalls (24hDRs) will validate the SQFFQ.\n\nThe SQFFQ will be administered to the validation study group during three non-consecutive calls, including one non-weekday (30-minute 24-h-recall computer-aided personal interview).\n\nPrimary Objective To measure the relative risk of specific dietary and lifestyle factors (smoking habit, alcohol intake, physical activity) for early-onset colorectal cancer in countries where eoCRC incidence is increasing versus stable\u002Fdecreasing",[121,122,123,124],"Colorectal Cancer","Early Onset Colorectal Cancer","Diet Habit","Risk Reduction",[126,127,128,129,130,131,132,133],"Early onset","Young onset","Young adult","Colon cancer","Rectal cancer","Cancer genetics","Cancer risk factors","Diet",{"date":70,"type":71},{"date":136,"type":71},"2022-12-05",{"date":138,"type":21},"2035-01",{"name":77,"class":78},8,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":5},"100627590","liquid-biopsy-and-machine-learning-for-early-colorectal-cancer-adenomas-lynch-cancers-and-residual-disease-detection-100627590","NCT07450612","Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection","BEACON","Inclusion Criteria:\n\n* All individuals included in the study need to have had a colonoscopy at the time of blood sampling.\n* Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.\n* Received standard pathological and endoscopic diagnosis and assessment for cohort assignment\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Inflammatory bowel disease",{"count":149,"type":21},1200,"This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.",[121,152,153,154,155,156,157,25,26,27,28,158,159,160,33,37,41,44,161],"Adenoma Colon","Adenoma Colon Polyp","Colon Adenoma","Colo-rectal Cancer","Colon Disease","Colon Neoplasm","LYN Gene Mutation","Mismatch Repair Deficiency","Mismatch Repair Gene Mutation","EPCAM Gene Mutation","2026-02-27",{"date":164,"type":71},"2026-03-04",{"date":166,"type":71},"2024-01-01",{"date":168,"type":21},"2031-08-15",{"name":77,"class":78},""]