[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06059963":3,"trial-entities:NCT06059963":73,"trial-summary:NCT06059963":77},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":16,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":51,"locations":54,"central_contacts":65,"overall_officials":70,"references":71,"see_also_links":72},"NCT06059963","CRC-US-003","A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation","RECRUITING","2026-12-01","2025-11","2025-11-10","2024-01-18","Universal Diagnostics","INDUSTRY",false,"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.",null,[18,19],"Colorectal Cancer","Advanced Adenocarcinoma",[21],"Advanced Precancerous Lesions","OBSERVATIONAL",[],{"count":25,"type":26},12000,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Signal-C™","Signal-C™ is a qualitative next generation sequencing-based in vitro diagnostic assay that uses targeted hybridization-based capture next-generation sequencing together with bioinformatics and machine learning algorithm for detection and combination of methylation and fragmentation associated DNA marker regions. Signal-C™ utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected via venipuncture in Streck Cell-Free DNA Blood Collection Tubes (BCTs).",[33],"Average risk",[35],{"measure":36,"description":37,"timeFrame":38},"Primary Objective","The primary objective of this study is to determine the sensitivity for CRC and specificity for advanced neoplasia (AN). Advance Neoplasia (AN) is defined as a final diagnosis of CRC or Advanced Precancerous Lesion (APL).","1 year",[40],{"measure":41,"description":42,"timeFrame":38},"Secondary Objective","To determine sensitivity for advanced precancerous lesions (APL). To determine NPV and PPV for colorectal cancer.","ALL","45 Years","84 Years",true,{"inclusion":48,"exclusion":49,"raw_text":50},[],[],"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.",[52,53],"ADULT","OLDER_ADULT",[55],{"facility":56,"status":7,"city":57,"state":58,"zip":59,"country":60,"contacts":61},"Gastroenterology Consultants of SW Virginia","Raonoke","Virginia","24014","United States",[62],{"name":63,"role":64},"Vishal Bhagat","CONTACT",[66],{"name":67,"role":64,"phone":68,"email":69},"Kara Mattox","(+1)3392085320","kara.mattox@universaldx.com",[],[],[],{"nct_id":4,"conditions":74,"biomarkers":76},[19,21,75],"Colorectal Carcinoma",[],{"nct_id":4,"found":46,"summary":78,"prompt_version":88},{"design":79,"status":80,"heading":81,"summary":82,"follow_up":83,"word_count":84,"commitments":85,"compensation":86,"drugs_mentioned":87},"This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It aims to include 12,000 participants.","completed","Signal-C Test Evaluation for Colorectal Cancer Screening","This study is evaluating a new test called Signal-C™. This test uses a blood sample to look for signs of colorectal cancer and advanced precancerous lesions (growths that could become cancer). We want to see how well Signal-C™ can find these conditions in people aged 45 to 84 who are considered to have an 'average risk' for colorectal cancer. To join, you would need to be between 45 and 84 years old and planning to have a standard colonoscopy. The study aims to enroll 12,000 participants. The current recruitment status is unclear, but the main goal is to see how well the Signal-C™ test performs over one year.","The primary objective is measured at 1 year.",108,"You would need to provide a blood sample before your colonoscopy, ideally within 90 days of the blood draw.","Not stated in the trial record.",[30],"v2"]