[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07649057":3,"trial-entities:NCT07649057":124,"trial-summary:NCT07649057":128},{"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":15,"conditions":17,"keywords":22,"study_type":24,"primary_purpose":15,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":15,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":58,"locations":61,"central_contacts":110,"overall_officials":117,"references":120,"see_also_links":121},"NCT07649057","26-187","A Study of a Urine Test to Detect Colorectal Cancer","Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa","RECRUITING","2028-06-11","2026-06","2026-06-15","2026-06-11","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is to find out whether a urine test can detect colorectal cancer (CRC) and precancerous polyps in participants living in Ghana, Tanzania, and South Africa.",[18,19,20,21],"Colorectal Cancer","Precancerous Polyp","Rectal Bleeding","CRC",[18,19,20,23,21,13,5],"Symptoms of Colorectal Cancer","OBSERVATIONAL",[],{"count":27,"type":28},210,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","3-metabolite biosensor","3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps",[35],"Participants with Colorectal Cancer\u002FCRC",[37],{"measure":38,"description":39,"timeFrame":40},"Sensitivity of 3-metabolite biosensor","The study will validate a 3-metabolite biosensor that identifies participants with colorectal cancer (CRC) and precancerous polyps in Ghana, Tanzania and South Africa. The primary aim is to show that the sensitivity and specificity in other regions are as good as the Nigerian estimates (i.e. 90% and 80% respectively).","up to 1 year",[],"ALL","18 Years",false,{"inclusion":46,"exclusion":56,"raw_text":57},[47,48,49,50,51,52,53,54,55],"Patient presents with one of the following:","Patients with symptoms of CRC (such as rectal bleeding for a week) -OR-","Patients who present for a screening colonoscopy -OR-","Has received one of the following within 3 weeks of the planned urine collection","Patients with a pathologic diagnosis of CRC either by colonoscopy or resection specimens -OR-","Patients with colonoscopy demonstrating adenomatous polyps -OR-","Patients with colonoscopy demonstrating no colon or premalignant or malignant pathology","Age ≥ 18","Willingness to participate in the study",[],"Inclusion Criteria:\n\n* Patient presents with one of the following:\n\n  * Patients with symptoms of CRC (such as rectal bleeding for a week) -OR-\n  * Patients who present for a screening colonoscopy -OR-\n  * Has received one of the following within 3 weeks of the planned urine collection\n\n    * Patients with a pathologic diagnosis of CRC either by colonoscopy or resection specimens -OR-\n    * Patients with colonoscopy demonstrating adenomatous polyps -OR-\n    * Patients with colonoscopy demonstrating no colon or premalignant or malignant pathology\n* Age ≥ 18\n* Willingness to participate in the study",[59,60],"ADULT","OLDER_ADULT",[62,75,87,98],{"facility":63,"status":8,"city":64,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":72},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","New York","10065","United States",[68],{"name":69,"role":70,"phone":71},"Peter Kingham, MD","CONTACT","212-639-5260",{"lat":73,"lon":74},40.71427,-74.00597,{"facility":76,"status":77,"city":78,"country":79,"contacts":80,"geoPoint":84},"Korle Bu Teaching Hospital (Data Collection Only)","NOT_YET_RECRUITING","Accra","Ghana",[81],{"name":82,"role":70,"email":83},"Antionette Bediako-Bowan, MD, FWACS, FGCS, PhD","abediako-bowan@ug.edu.gh",{"lat":85,"lon":86},5.55602,-0.1969,{"facility":88,"status":77,"city":89,"country":90,"contacts":91,"geoPoint":95},"Wits Donald Gordon Medical Centre (Data Collection Only)","Johannesburg","South Africa",[92],{"name":93,"role":70,"phone":94},"Brendan Bebington, MBChB, FCS","011 7263390\u002F1",{"lat":96,"lon":97},-26.20227,28.04363,{"facility":99,"status":77,"city":100,"country":101,"contacts":102,"geoPoint":107},"Kilimanjaro Christian Medical Centre (Data Collection Only)","Moshi","Tanzania",[103],{"name":104,"role":70,"phone":105,"email":106},"Alex Mremi, PhD","+255 717 083 983","alex.mremi@kcmcu.ac.tz",{"lat":108,"lon":109},-3.35,37.33333,[111,113],{"name":69,"role":70,"phone":71,"email":112},"kinghamP@mskcc.org",{"name":114,"role":70,"phone":115,"email":116},"Alexia Iasonos, PhD","646-227-3557","iasonosa@mskcc.org",[118],{"name":69,"affiliation":13,"role":119},"PRINCIPAL_INVESTIGATOR",[],[122],{"label":13,"url":123},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":125,"biomarkers":127},[126,19],"Colorectal Carcinoma",[],{"nct_id":4,"found":44,"summary":15,"prompt_version":15}]