Measuring MMP-14 protein in blood exosomes to help detect colorectal cancer
Performance of Serum Matrix Metalloproteinase (MMP14) Assay as a Novel Biomarker for Colorectal Cancer Screening in Subjects From 50 to 74 Years Old Referred for Colonoscopy After Positive FIT
This research tries to see if measuring MMP-14 in tiny blood particles called exosomes can help detect colorectal cancer in people with a positive FIT who are scheduled for colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 650 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CHU de Reims Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Reims) |
| Trial ID | NCT06955767 on ClinicalTrials.gov |
What this trial studies
This is a multicenter cross-sectional interventional study recruiting adults with a positive fecal immunochemical test (FIT) who are booked for colonoscopy. After consent, two 5 mL blood tubes are drawn and plasma is processed, frozen, and sent to a central lab where exosomes are isolated and characterized and MMP-14 protein levels are measured. Results will compare MMP-14 levels between patients with and without colorectal lesions found at colonoscopy. The goal is to determine whether exosomal MMP-14 could serve as a blood-based marker to better triage FIT-positive patients.
Who should consider this trial
Good fit: Adults with a positive FIT result who are scheduled for a total colonoscopy under general anesthesia and who can provide informed consent are eligible.
Not a fit: People currently receiving chemotherapy, with another active or recently treated cancer (within five years), legally protected individuals, or those without a positive FIT would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, this marker could help reduce unnecessary follow-up colonoscopies by better identifying which FIT-positive patients are likely to have colorectal lesions.
How similar studies have performed: Early pilot data reported by the team found higher exosomal MMP-14 in colorectal cancer patients, so this approach has promising preliminary evidence but is not yet validated in large populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Individuals presenting for colonoscopy with a positive FIT result. * Positive fecal immunoassay requiring total colonoscopy under general anesthesia. * Persons having agreed to participate in the study (signed consent form) * Adults affiliated to a health insurance scheme. Exclusion criteria: * History of other cancer not in remission or in remission for less than five years (with the exception of cervical cancer or basal cell skin cancer treated with curative intent) * Patients undergoing chemotherapy * Legally protected individuals
Where this trial is running
Reims
- Damien JOLLY — Reims, France (Recruiting)
Study contacts
- Study coordinator: Laurent RAMONT
- Email: lramont@chu-reims.fr
- Phone: 03 26 78 78 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.