Colorectal AdenocarcinomaEXOSCOL02NCT06955767
Measurement of MMP-14 Protein, a Potential New Marker for Colorectal Cancer Detection, in Plasma Vesicles Named Exosomes
A study testing Blood will be drawn from 2 additional tubes of 5 ml each in people with Colorectal Adenocarcinoma, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- Blood will be drawn from 2 additional tubes of 5 ml each
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2026to 2 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Laurent RAMONT, 03 26 78 78 01 ext. 0033, lramont@chu-reims.fr
Olivier BOUCHE, 03 26 78 31 13 ext. 0033, obouche@chu-reims.fr
About this study
Official title: 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
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).
Read the detailed description
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.
Non-inclusion 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
- Patients protected by law This is a cross-sectional multicenter interventional study. Patients will be recruited from the Hepato-Gastroenterology departments of the CHU de Reims, CHU de Dijon, CHU de Nancy, CHU de Besançon, CH de Châlons-en-Champagne, Institut Jean Godinot de Reims, CHU de Strasbourg, CH de Charleville Mézières and CH d'Epernay.
Once consent has been signed and the patient has been included in the study, blood will be drawn from 2 additional tubes of 5 ml each, either in the consultation room or in the operating room, when the infusion is set up for colonoscopy under general anaesthetic. Plasma will be collected at the various participating facilities (2 x 5mL EDTA tubes), centrifuged at 1000g for 10 minutes, then frozen at -80°C. Samples will then be sent to the Reims University Hospital Biology Department for storage before analysis.
The isolation of exosomes from the patient's plasma and their characterization: size, number (determined using the Malvern Panalytical NanoSight NS300), and MMP14 concentration (determined by enzyme-linked immunosorbent assay), will be carried out at the CNRS UMR7369 "Matrice Extracellulaire et Dynamique Cellulaire (MEDyC)" unit at the University of Reims Champagne Ardenne.
- Conditions
- Colorectal Adenocarcinoma
- Being tested
- Blood will be drawn from 2 additional tubes of 5 ml each
- Keywords
- Colorectal Adenocarcinoma, Exosomes, Matrix Metalloproteinase 14, MMP-14
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood will be drawn from 2 additional tubes of 5 ml eachOther
Blood will be drawn from 2 additional tubes of 5 ml each
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood will be drawn from 2 additional tubes of 5 ml each |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 30 minutes
Secondary outcomes (5)
Serum Matrix Metalloproteinase (MMP14) MMP14 Concentration: Normal vs. Adenoma
Concentration of Serum Matrix Metalloproteinase (MMP14) depending on whether the colonoscopy was normal or revealed an adenoma
Measured: At 30 minutes
Serum MMP14 Concentration according to adenoma characteristics
Concentration of Serum Matrix Metalloproteinase (MMP14) according to adenoma characteristics
Measured: At 30 minutes
Serum MMP14 Concentration between groups: normal colonoscopy vs. adenoma and cancerous lesions
Comparison of exosomal plasma MMP14 concentration between groups: normal colonoscopy vs. adenoma and cancerous lesions
Measured: At 30 minutes
Diagnostic performances of Serum MMP14
Sensitivity and specificity
Measured: At 30 minutes
Concentration of markers derived from circulating tumor exosomes in the context of colorectal cancer
Mean value of markers derived from circulating tumor exosomes
Measured: At 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start2 Apr 2026
- Primary completion2 Apr 2028 (estimated)
- Study completion2 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955767
- Sponsor's protocol ID
- PR25047
- Acronym
- EXOSCOL02
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06955767
- Acronym / sponsor ID
- EXOSCOL02 / PR25047
- Conditions
- Colorectal Adenocarcinoma
- Keywords
- Colorectal Adenocarcinoma, Exosomes, Matrix Metalloproteinase 14, MMP-14
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 2 Apr 2028 (estimated)
- Study completion
- 2 Apr 2028 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Non-inclusion 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
- Patients protected by law This is a cross-sectional multicenter interventional study. Patients will be recruited from the Hepato-Gastroenterology departments of the CHU de Reims, CHU de Dijon, CHU de Nancy, CHU de Besançon, CH de Châlons-en-Champagne, Institut Jean Godinot de Reims, CHU de Strasbourg, CH de Charleville Mézières and CH d'Epernay.
Once consent has been signed and the patient has been included in the study, blood will be drawn from 2 additional tubes of 5 ml each, either in the consultation room or in the operating room, when the infusion is set up for colonoscopy under general anaesthetic. Plasma will be collected at the various participating facilities (2 x 5mL EDTA tubes), centrifuged at 1000g for 10 minutes, then frozen at -80°C. Samples will then be sent to the Reims University Hospital Biology Department for storage before analysis.
The isolation of exosomes from the patient's plasma and their characterization: size, number (determined using the Malvern Panalytical NanoSight NS300), and MMP14 concentration (determined by enzyme-linked immunosorbent assay), will be carried out at the CNRS UMR7369 "Matrice Extracellulaire et Dynamique Cellulaire (MEDyC)" unit at the University of Reims Champagne Ardenne.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serum Matrix Metalloproteinase (MMP14) | Experimental | Other: Blood will be drawn from 2 additional tubes of 5 ml eachBlood will be drawn from 2 additional tubes of 5 ml each, either in the consultation room or in the operating room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood will be drawn from 2 additional tubes of 5 ml eachBlood will be drawn from 2 additional tubes of 5 ml each | Other | Serum Matrix Metalloproteinase (MMP14) |
Primary outcome
Serum Matrix Metalloproteinase (MMP14) : normal versus a cancerous lesion
Time frame: At 30 minutes
Concentration of Serum Matrix Metalloproteinase (MMP14) depending on whether the colonoscopy was normal or revealed a cancerous lesion
5 secondary outcomes
Serum Matrix Metalloproteinase (MMP14) MMP14 Concentration: Normal vs. Adenoma
Time frame: At 30 minutes
Serum MMP14 Concentration according to adenoma characteristics
Time frame: At 30 minutes
Serum MMP14 Concentration between groups: normal colonoscopy vs. adenoma and cancerous lesions
Time frame: At 30 minutes
Diagnostic performances of Serum MMP14
Time frame: At 30 minutes
Concentration of markers derived from circulating tumor exosomes in the context of colorectal cancer
Time frame: At 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood will be drawn from 2 additional tubes of 5 ml each in people with Colorectal Adenocarcinoma, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent RAMONT (03 26 78 78 01 ext. 0033, lramont@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Matrix Metalloproteinase (MMP14) : normal versus a cancerous lesion (time frame: At 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.