NCT06059963 A Prospective, Multi-center, Observational Study for Signal-C Test Evaluation
| NCT ID | NCT06059963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universal Diagnostics |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 12,000 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12,000 participants in total. It began in 2024-01-18 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects aged 45-84 years at time of consent 2. Intended to undergo a standard-of-care screening colonoscopy 3. Considered by a physician or healthcare provider as being of 'average risk' for CRC 4. 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. 5. Willing to consent to follow-up for one year as per protocol 6. Able and willing to sign informed consent Exclusion Criteria: 1. Undergoing colonoscopy for investigation of CRC risk symptoms 2. Has undergone colonoscopy within preceding 9 years 3. Positive FIT/FOBT result within the previous 12 months (+/- 3 months) 4. Has completed Cologuard or Epi proColon testing within the previous 3 years. 5. Has undergone a CT colonography in the prior 4 years. 6. History of colorectal cancer. 7. History of any malignancy within prior 5 years. 8. Known diagnosis of inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease (CD). 9. Positive family history of colorectal cancer, defined as having a first- degree relative (parent, sibling, or child) with CRC diagnosed at age \<60 years or with more than one first-degree relative diagnosed with CRC at any age. 10. Known hereditary/germline risk of colorectal cancer (for example, Lynch syndrome or Hereditary Non-Polyposis CRC \[HNPCC\], or Familial Adenomatous Polyposis \[FAP\]). 11. 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. 12. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study. 13. Known pregnancy at informed consent, blood sample collection, and during study participation. 14. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06059963 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 84 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06059963 currently recruiting?
Yes, NCT06059963 is actively recruiting participants. Contact the research team at kara.mattox@universaldx.com for enrollment information.
Where is the NCT06059963 trial being conducted?
This trial is being conducted at Raonoke, United States.
Who is sponsoring the NCT06059963 clinical trial?
NCT06059963 is sponsored by Universal Diagnostics. The trial plans to enroll 12,000 participants.
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