[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06931860":3,"trial-entities:NCT06931860":99,"trial-summary:NCT06931860":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":52,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":80,"locations":82,"central_contacts":92,"overall_officials":93,"references":97,"see_also_links":98},"NCT06931860","80312400","Head to Head Trial of Mailed Cologuard to Mailed FIT","Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach","ENROLLING_BY_INVITATION","2027-09","2025-09","2025-09-09","2025-09-05","University of California, San Diego","OTHER",true,"The objective of this study is to measure the comparative effectiveness of mailed outreach of two stool based tests, multi-target stool DNA (Cologuard) and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.","Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 12 months of randomization will be measured as the primary outcome, in addition to secondary outcomes of Cologuard or FIT positivity rate measured within 12 months of randomization, and follow-up colonoscopy uptake and CRC incidence, measured within 24 months of randomization.",[19,20,21,22],"Colorectal Cancer Screening","Fecal Immunochemical Test","Multi-target Stool DNA","Colorectal Cancer (CRC)",[24,25,26,27,28],"screening","early detection","colorectal cancer","stool blood test","mailed outreach","INTERVENTIONAL","SCREENING",[32],"NA",{"count":34,"type":35},400,"ESTIMATED",[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DIAGNOSTIC_TEST","Cologuard","Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.",[42],"Mailed Cologuard Outreach",{"type":38,"name":20,"description":44,"armGroupLabels":45},"Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.",[46],"Mailed Fecal immunochemical test Outreach",[48],{"measure":49,"description":50,"timeFrame":51},"Proportion of Colorectal cancer screening completion","The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)","Within 12 months of randomization",[53,56,60],{"measure":54,"description":55,"timeFrame":51},"Proportion of Abnormal stool blood test results","Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.",{"measure":57,"description":58,"timeFrame":59},"Proportion of Follow-up colonoscopy after abnormal stool blood test result","Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy","Within 24 months after randomization",{"measure":61,"description":62,"timeFrame":59},"Colorectal cancer incidence","Number of colorectal cancers detected during study period","ALL","45 Years","49 Years",false,{"inclusion":68,"exclusion":74,"raw_text":79},[69,70,71,72,73],"Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health","≥1 UCSD Health System health visit within the last year","Resides in San Diego or Imperial County","Currently not up to date with CRC screening","Insured by private, public or other health insurance.",[75,76,77,78],"Up-to-date with screening","Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer.","Prior history of colectomy","Lack of health insurance","Inclusion Criteria:\n\n* Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health\n* ≥1 UCSD Health System health visit within the last year\n* Resides in San Diego or Imperial County\n* Currently not up to date with CRC screening\n* Insured by private, public or other health insurance.\n\nExclusion Criteria:\n\n* Up-to-date with screening\n* Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer.\n* Prior history of colectomy\n* Lack of health insurance",[81],"ADULT",[83],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"University of California San Diego","La Jolla","California","92093","United States",{"lat":90,"lon":91},32.84727,-117.2742,[],[94],{"name":95,"affiliation":13,"role":96},"Joshua Demb, PhD, MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Colorectal Carcinoma",[],{"nct_id":4,"found":66,"summary":104,"prompt_version":104},null]