Blood test could spot colon cancer early – 12,000 volunteers needed
NCT ID NCT06059963
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new blood test called Signal-C that looks for DNA fragments in the blood to detect colorectal cancer and advanced precancerous growths. Researchers will enroll 12,000 people aged 45-84 who are at average risk and already scheduled for a routine screening colonoscopy. The goal is to see how accurate the blood test is compared to the colonoscopy results.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 12,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients aged between 45 and 84, who are at average risk of developing colorectal cancer, and are scheduled for a standard-of-care screening colonoscopy. Approximately 12,000 subjects will need to be enrolled. Enrollment is event-driven and will be stopped when the required number of CRC cases have been confirmed with a final histopathological diagnosis.
- Ages
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45 to 84 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gastroenterology Consultants of SW Virginia
RECRUITINGRaonoke, Virginia, 24014, United States
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