[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universal Diagnostics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100616810","collection-of-samples-from-the-united-states-population-for-optimization-and-evaluation-of-colorectal-cancer-crc-plasma-circulating-free-dna-cfdna-marker-panel-performance-100616810",false,"NCT07310446","Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance","Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance (PROVE)","PROVE","Inclusion Criteria:\n\n* Arm A: Diagnosed with CRC\n* Arm B: Undergoing screening with colonoscopy for CRC\n\nExclusion Criteria:\n\n* Arm A: Undergoing treatment for CRC,\n* Arm B: Past history of CRC",true,"ALL","45 Years","84 Years",{"count":22,"type":23},6500,"ESTIMATED","OBSERVATIONAL","This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.",[27],"Colorectal Cancer",[29,30],"colorectal","screening","RECRUITING","2025-12-15",{"date":34,"type":35},"2025-12-30","ACTUAL",{"date":37,"type":35},"2023-07-31",{"date":39,"type":23},"2027-07",{"name":41,"class":42},"Universal Diagnostics","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100520699","a-prospective-multi-center-observational-study-for-signal-c-test-evaluation-100520699","NCT06059963","A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation","Inclusion Criteria:\n\n1. Subjects aged 45-84 years at time of consent\n2. Intended to undergo a standard-of-care screening colonoscopy\n3. Considered by a physician or healthcare provider as being of 'average risk' for CRC\n4. Willing to consent to blood draw prior to bowel preparatory procedures or undergoing colonoscopy ideally within 90 days of the date of the investigational blood draw.\n5. Willing to consent to follow-up for one year as per protocol\n6. Able and willing to sign informed consent\n\nExclusion Criteria:\n\n1. Undergoing colonoscopy for investigation of CRC risk symptoms\n2. Has undergone colonoscopy within preceding 9 years\n3. Positive FIT\u002FFOBT result within the previous 12 months (+\u002F- 3 months)\n4. Has completed Cologuard or Epi proColon testing within the previous 3 years.\n5. Has undergone a CT colonography in the prior 4 years.\n6. History of colorectal cancer.\n7. History of any malignancy within prior 5 years.\n8. Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD).\n9. Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age \\\u003C60 years or with more than one first-degree relative diagnosed with CRC at any age.\n10. Known hereditary\u002Fgermline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \\[HNPCC\\], or Familial Adenomatous Polyposis \\[FAP\\]).\n11. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.\n12. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.\n13. Known pregnancy at informed consent, blood sample collection, and during study participation.\n14. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy.",{"count":51,"type":23},12000,"To evaluate the performance characteristics of Signal-C™ a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions (APL) in an average risk screening population for 45 and over.",[27,54],"Advanced Adenocarcinoma",[56],"Advanced Precancerous Lesions","2025-11-05",{"date":59,"type":35},"2025-11-10",{"date":61,"type":35},"2024-01-18",{"date":63,"type":23},"2026-12-01",{"name":41,"class":42},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":72,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":83},"100423348","collection-of-samples-usoptival-study-100423348","NCT04792684","Collection of Samples USOPTIVAL Study","Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance (\"USOPTIVAL\")","Inclusion Criteria:\n\nArm A:\n\n1. Must be 45-84 years of age.\n2. Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery.\n3. Able to comprehend, sign, and date the written informed consent document.\n\nArm B:\n\n1. Must be 45-84 years of age.\n2. Able and willing to undergo a standard-of-care screening colonoscopy within 60 days.\n3. Able to comprehend, sign, and date the written informed consent document.\n\nExclusion Criteria:\n\nArm A Only:\n\n1\\. Subject with curative biopsy during colonoscopy.\n\nArm B Only:\n\n1. Subjects with positive FIT Test results in the 6 months preceding enrollment.\n2. Subject has a current diagnosis of cancer.\n\nArms A \\& B:\n\n1. Subject has a personal history of aerodigestive or digestive tract cancers.\n2. Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.\n3. Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer:\n\n   1. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.\n   2. Familial adenomatous polyposis (\"FAP\", including attenuated FAP).\n   3. Hereditary non-polyposis colorectal cancer syndrome (\"HNPCC\" or \"Lynch Syndrome\").\n   4. Serrated polyposis syndrome\n   5. 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer.\n   6. One first-degree relative with CRC diagnosed before the age of 60.\n4. A significant disease which, in the Investigator's opinion, would exclude the subject from the study.\n5. Legal incapacity or limited mental capacity.\n6. Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent.\n7. The patient has a known or documented previous or current medical history of infectious diseases that can be transmitted through blood (E.g. Hepatitis, HIV, etc.), including patients that have been treated, are currently being treated, or have not been treated for that conditions.\n8. The patient is known to be pregnant when recruited or during her participation in the study.",{"count":73,"type":23},1300,"A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.",[76,77],"Colorectal Cancer (CRC)","Advanced Adenomas (AA)",{"date":59,"type":35},{"date":80,"type":35},"2020-12-30",{"date":34,"type":23},{"name":41,"class":42},16,""]