Measurement of MMP-14 Protein, a Potential New Marker for Colorectal Cancer Detection, in Plasma Vesicles Named Exosomes

NCT06955767 | Recruiting

• 1 other identifier: PR25047
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the third most common cancer in men, and the second most common in women. Screening for colorectal cancer is based on the search for blood in the stool using fecal immunochemical test (FIT). Occult bleeding is an indication for colonoscopy. In a FIT positive population, 60% of colonoscopies are negative, 34% diagnose an adenomatous lesion, and 6% a cancer. The identification of new biological markers could reduce the number of colonoscopies performed. Cancer cells release extracellular vesicles that contain proteins, mRNAs, DNA, which they can transfer to neighbouring or distant cells. The use of exosomal proteins as novel tumor markers looks very promising. We performed a pilot study comparing the levels of different exosomal proteins in 74 subjects which was recently accepted for publication in Journal of Clinical Laboratory Analysis. Comparison of results showed that only matrix metalloproteinase 14 (MMP14) was significantly higher in patients with colorectal cancer or adenoma than in people with normal colonoscopy. The primary objective of the current study is to determine the best cut-off value of MMP-14 for colorectal cancer screening and to evaluate the performance (Sensitivity, Specificity…) associated to this cut-off value. The secondary objective will be to determine the best cut-off value of MMP-14 for colorectal adenomas screening and to evaluate its performance. For this purpose, 650 patients, seen for diagnostic colonoscopy following a positive FIT test, will be included in the study. After blood collection and exosome isolation, MMP-14 will be measured using a quantitative test (enzyme-linked immunosorbent assay) and the results will be associated with colonoscopy results to determine the sensitivity, specificity, positive predictive value (PPV) and net present value (NPV).

Conditions

Colorectal Adenocarcinoma

Keywords

Colorectal Adenocarcinoma; Exosomes; Matrix Metalloproteinase 14; MMP-14

Outcome Measures

Primary Outcomes (1)

• Serum Matrix Metalloproteinase (MMP14) : normal versus a cancerous lesion

  Concentration of Serum Matrix Metalloproteinase (MMP14) depending on whether the colonoscopy was normal or revealed a cancerous lesion

  At 30 minutes

Secondary Outcomes (5)

• Serum Matrix Metalloproteinase (MMP14) MMP14 Concentration: Normal vs. Adenoma

  At 30 minutes

• Serum MMP14 Concentration according to adenoma characteristics

  At 30 minutes

• Serum MMP14 Concentration between groups: normal colonoscopy vs. adenoma and cancerous lesions

  At 30 minutes

• Diagnostic performances of Serum MMP14

  At 30 minutes

• Concentration of markers derived from circulating tumor exosomes in the context of colorectal cancer

  At 30 minutes

Study Arms (1)

Serum Matrix Metalloproteinase (MMP14)

EXPERIMENTAL

Blood will be drawn from 2 additional tubes of 5 ml each, either in the consultation room or in the operating room.

Other: Blood will be drawn from 2 additional tubes of 5 ml each

Interventions

Blood will be drawn from 2 additional tubes of 5 ml each OTHER

Blood will be drawn from 2 additional tubes of 5 ml each

Serum Matrix Metalloproteinase (MMP14)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

Central Study Contacts

Laurent RAMONT

CONTACT

03 26 78 78 01; lramont@chu-reims.fr

Olivier BOUCHE

CONTACT

03 26 78 31 13; obouche@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 2, 2025
• Study Start: April 2, 2026
• Primary Completion (Estimated): April 2, 2028
• Study Completion (Estimated): April 2, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

FR (1)