[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-adenoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-adenoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,73,94,120],{"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":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100599884","china-colorectal-cancer-screening-trial-1-c-cost1-100599884",false,"NCT07090291","China Colorectal Cancer Screening Trial 1 (C-Cost1)","China Colorectal Cancer Screening Trial 1 (C-Cost1): Colonoscopy Versus FIT Versus FIT Plus Blood Test in the Average Risk Population","Inclusion Criteria:\n\n1. Age: 45-74 years old;\n2. In good general condition, with normal mental state and voluntarily signing the informed consent form;\n\nExclusion Criteria:\n\n1. Personal history of colorectal cancer or precancerous lesions;\n2. History of previous colonrectal resection surgery;\n3. Diagnosed with cancer before enrollment or currently receiving any cancer-related treatment;\n4. Having received colonoscopy, flexible sigmoidoscopy, CT colonography and other examinations within the past 5 years;\n5. Having received FIT or FIT-sDNA or cfDNA test within the past 1 year;\n6. Symptomatic lower gastrointestinal diseases or symptoms suggesting the need for diagnostic colonoscopy for confirmation;\n7. Accompanied by severe diseases that are not suitable for colorectal cancer screening;","ALL","45 Years","74 Years",{"count":20,"type":21},60300,"ESTIMATED","INTERVENTIONAL",[24],"NA","Colorectal cancer (CRC) is one of the most common malignancies in China. Currently, its incidence rate is increasing at a rate of 4% per year, exceeding the global annual average growth rate. Screening and early diagnosis of colorectal cancer and precancerous lesions are key measures to reduce the disease burden of colorectal cancer in China. In previous clinical studies, colorectal cancer screening in high risk population received extensive attention. However, it cannot be ignored that the majority of sporadic colorectal cancers occur in the average risk population. Therefore, there is an urgent need to develop new approach for colorectal cancer screening in the average risk population in China.\n\nFecal Immunochemical Testing (FIT) initial screening followed by diagnostic colonoscopy is widely recommended by colorectal cancer screening guidelines worldwide. The current colorectal cancer screening approach faces challenges including limited sensitivity of initial screening technologies and insufficient population coverage in organized screening programs in China. As initial screening technologies, non-invasive blood tests which detects cfDNA methylation have been reported to have higher accuracy than FIT in detecting colorectal cancer. However, There is a lack of randomized controlled trials (RCTs) comparing the effectiveness of colonoscopy, FIT and FIT plus blood test for colorectal cancer screening.\n\nIn China Colorectal Cancer Screening Trial 1 (C-Cost1), we propose to perform a multicenter, cluster randomized, parallel group trial directly comparing colonoscopy with FIT and with FIT plus blood test in the average risk population in China. The main research hypotheses are: (1) The screening protocol of FIT group (Group B) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years; (2) The screening protocol of FIT plus blood test group (Group C) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years. Both of the two hypotheses should be met.",[27,28],"Colorectal Cancer","Advanced Adenoma",[30],"FIT; FIT plus blood test; cfDNA methylation; Colorectal cancer; Advanced colorectal adenoma; Early screening; Average risk population","RECRUITING","2026-04-12",{"date":34,"type":35},"2026-04-14","ACTUAL",{"date":37,"type":35},"2025-08-08",{"date":39,"type":21},"2035-07",{"name":41,"class":42},"Zhejiang University","OTHER",7,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100484809","a-novel-oral-synbiotic-formula-in-reducing-advanced-adenoma-recurrence-and-colorectal-neoplasia-related-bacterial-gene-markers-100484809","NCT05592886","A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers","A Multicenter, Double Blinded Randomized Controlled Trial of a Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers","Inclusion Criteria:\n\n* Subjects who have advanced colorectal neoplasia\\* removed and confirmed by histopathology;\n* They have received high quality colonoscopies before or during endoscopic resection (defined as a full colonoscopy with successful caecal intubation, and a Boston Bowel Preparation Scale ≧2 in each colonic segment) with no residual colorectal neoplasia;\n* Aged 18-90 years old;\n* Written informed consent obtained\n\n  * An advanced colorectal neoplasia is defined as an advanced adenoma, sessile serrated lesion or non-invasive colorectal cancer (stage Tis or T1a). Advanced adenoma is defined as an adenoma larger than 10mm, and\u002For with villous component ≥20%, and\u002For harboring high grade dysplasia.\n\nExclusion Criteria:\n\n* Known residual colorectal neoplasia not removed (except hyperplastic polyps);\n* Contraindications to endoscopic resection due to deep submucosal invasion (stage T1b or above);\n* Prior surgical resection of colon;\n* Personal history of hereditary polyposis syndrome or inflammatory bowel disease;\n* Known pregnancy or lactation;\n* Immunocompromised status (e.g. on immunosuppressants (except 5-aminosalicylic acid or short term use of corticosteroids \\\u003C4 weeks), on chemotherapy, bone marrow or solid organ transplant, human immunodeficiency virus, congenital immune deficiency);\n* Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);\n* Refusal to undergo surveillance colonoscopy.","18 Years","90 Years",{"count":54,"type":21},649,[24],"This multicenter, double blinded randomized controlled trial aims to assess the efficacy of a novel oral synbiotic formula (SMT04) in reducing advanced adenoma recurrence and colorectal neoplasia-related bacterial gene markers after endoscopic resection of colorectal advanced neoplasia.",[58,59,27,28],"Colorectal Neoplasms","Colorectal Adenoma",[61,62],"Adenoma recurrence","Bacterial marker","2025-07-29",{"date":65,"type":35},"2025-08-01",{"date":67,"type":35},"2022-12-15",{"date":69,"type":21},"2027-12-31",{"name":71,"class":42},"Chinese University of Hong Kong",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":4},"100599885","china-colorectal-cancer-screening-trial-2-c-cost2-100599885","NCT07090304","China Colorectal Cancer Screening Trial 2 (C-Cost2)","China Colorectal Cancer Screening Trial 2 (C-Cost2): FIT Versus FIT-sDNA in the Average Risk Population",{"count":80,"type":21},7504,[24],"Colorectal cancer (CRC) is one of the most common malignancies in China. Currently, its incidence rate is increasing at a rate of 4% per year, exceeding the global annual average growth rate. Screening and early diagnosis of colorectal cancer and precancerous lesions are key measures to reduce the disease burden of colorectal cancer in China. In previous clinical studies, colorectal cancer screening in high risk population received extensive attention. However, it cannot be ignored that the majority of sporadic colorectal cancers occur in the average risk population. Therefore, there is an urgent need to develop new approach for colorectal cancer screening in the average risk population in China.\n\nFecal Immunochemical Testing (FIT) initial screening followed by diagnostic colonoscopy is widely recommended by colorectal cancer screening guidelines worldwide. The current colorectal cancer screening approach faces challenges including limited sensitivity of initial screening technologies and insufficient population coverage in organized screening programs in China. Stool DNA tests detect DNA biomarkers of tumor cells in the stool and have higher sensitivity in detecting advanced colorectal neoplasms. USPSTF has recommended FIT-sDNA as initial screening tests in the average risk population. Colorectal Cancer Early Screening in China (Clear-C) trial has reported FIT-sDNA had higher sensitivity than FIT in detecting advanced colorectal neoplasms among high risk population, yet there is a lack of randomized controlled trials (RCTs) directly comparing the effectiveness of FIT and FIT-sDNA for colorectal cancer screening in the average risk population in China.\n\nIn China Colorectal Cancer Screening Trial 2 (C-Cost2), we propose to perform a multicenter, individual-level randomized, parallel group trial directly comparing FIT and FIT-sDNA in the average risk population in China. The main research hypothesis is that the screening protocol of FIT-sDNA group (Group B) has a superior detection rate of advanced colorectal neoplasms compared to the FIT group (Group A).",[27,28],[85],"FIT; FIT-sDNA; Colorectal cancer; Advanced colorectal adenoma; Early screening; Average risk population","NOT_YET_RECRUITING","2025-07-28",{"date":63,"type":35},{"date":90,"type":21},"2025-07",{"date":92,"type":21},"2028-11",{"name":41,"class":42},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100450335","diagnostic-accuracy-of-m3-in-predicting-colorectal-advanced-adenoma-recurrence-m3-aa-100450335","NCT05144152","Diagnostic Accuracy of M3 in Predicting Colorectal Advanced Adenoma Recurrence (M3-AA)","A Prospective Study to Assess the Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) in Predicting Colorectal Advanced Adenoma Recurrence","M3-AA","Inclusion Criteria:\n\n1. Known colorectal adenomas during index colonoscopy;\n2. Available baseline M3 and FIT results before index colonoscopy;\n3. Aged ≥18 years old;\n4. Written informed consent obtained.\n\nExclusion Criteria:\n\n1. Refusal or unfit to undergo surveillance colonoscopy;\n2. Incomplete colonoscopy, incomplete removal of colorectal adenomas, or inadequate bowel preparation (defined as Boston Bowel Preparation Scale score 0 or 1 in any colonic segment) at index colonoscopy;\n3. Previous colonic resection;\n4. Personal history of colorectal cancer;\n5. Personal history of polyposis syndrome;\n6. Personal history of inflammatory bowel disease;\n7. Known pregnancy or lactation;\n8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);",{"count":103,"type":21},600,"OBSERVATIONAL","The investigators aim to evaluate the diagnostic accuracy of FIT and the novel panel of four bacterial gene markers collectively named as M3, to detect recurrent advanced adenomas in patients with history of colonic adenomas.",[59,28,107],"Colorectal Polyp",[109,62,110],"FIT","Colonoscopy","2024-08-26",{"date":113,"type":35},"2024-08-27",{"date":115,"type":35},"2021-12-13",{"date":117,"type":21},"2025-06-15",{"name":71,"class":42},1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100533038","multi-omics-study-for-early-detection-of-colorectal-cancer-moed-crc-100533038","NCT06220617","Multi-omics Study for Early Detection of Colorectal Cancer (MOED-CRC)","Multi-omics Study for Early Detection of Colorectal Cancer Based on Liquid Biopsy Technology","Inclusion Criteria for Case Arm:\n\n1. Aged over 18 years.\n2. Participants confirmed with colorectal adenocarcinoma or advanced adenoma through colonoscopy and pathological examination.\n3. Provision of informed consent prior to any study specific procedures, sampling, and analyses.\n\nInclusion Criteria for Control Arm:\n\n1. Individuals of \"General risk arm\" should meet all the following criteria:\n\n   1. No history of colorectal adenomas or sessile serrated polyps.\n   2. No history of inflammatory bowel disease (8-10 years ).\n   3. No family history (first-degree relatives) of colorectal cancer.\n2. Individuals of \"High-risk arm\" should meet at least one of the following criteria:\n\n   1. Asia-Pacific Colorectal Screening (APC) score ≥ 3.\n   2. Family history (first-degree relatives) of colorectal cancer.\n   3. History of positive fecal occult blood test.\n   4. Any 2 of the following: chronic diarrhea, chronic constipation, mucous bloody stools, history of psychological stimulation, history of chronic appendicitis or appendectomy, history of chronic biliary disease or cholecystectomy.\n   5. Individuals with inflammatory bowel disease.\n3. All participants must be confirmed not to have colorectal malignancy or advanced adenomas through colonoscopy.\n4. Provision of informed consent prior to any study specific procedures, sampling, and analyses.\n\nExclusion Criteria:\n\n1. History of other malignant tumors (excluding non-melanoma skin cancer).\n2. Prior or related treatments previously (including colorectal cancer or advanced adenoma surgery, endoscopic treatment, chemotherapy, targeted therapy, immunotherapy, radiation, neoadjuvant therapy, etc.).\n3. Patients with hereditary colorectal diseases (including Lynch syndrome, familial CRC type X (FCCX), familial adenomatous polyposis (FAP), MUTHY-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), serrated polyposis syndrome (SPS), etc.).\n4. Usage of anti-tumor drugs such as methotrexate, cyclophosphamide, mercaptopurine, and bendamustine for other diseases within 30 days before blood collection.\n5. Prior blood transfusion (including blood components) within the past 2 weeks.\n6. Prior organ transplantation, bone marrow transplantation, or stem cell transplantation.\n7. Pregnancy women.\n8. Prior or current anti-infection treatment within 14 days before blood collection.\n9. Inability to comply with study procedures such as blood collection and related examinations.\n10. Deemed unsuitable for participation in the clinical trial by the investigator.",true,{"count":129,"type":21},3600,"The primary objective of the study is to screen multi-omics markers in blood samples and construct a prediction model for CRC based on liquid biopsy, and we will further optimize the prediction model by validating its clinical performance externally.",[27,132,133,28],"Adenomatous Polyps","Adenoma",[27,58,132,133,135],"Advanced adenoma","2024-01-28",{"date":138,"type":35},"2024-01-30",{"date":140,"type":35},"2024-01-11",{"date":142,"type":21},"2027-06-30",{"name":41,"class":42},6]