Circulating MarkersCOCA-MACSNCT02872779
Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer
A study testing Blood sampling for free mutant DNA analysis in people with Circulating Markers and Metastatic Colorectal Cancer, run by University Hospital, Rouen at 1 site in France.
Trial summary
The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Markers, Metastatic Colorectal Cancer
- What is being tested?
- Blood sampling for free mutant DNA analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2016to 10 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or female, age superior to 18 years.
- Histologically confirmed metastatic colorectal adenocarcinoma.
- Measurable disease according to the RECIST 1.1 guideline
- ECOG performance status <3.
- Disease requiring IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) every 14 days
- No prior chemotherapy for this adenocarcinoma with the exception of adjuvant chemotherapy
- Signed and dated informed consent document.
Who cannot join
- Medical history of cancer within 5 years
- Medical contraindication for a treatment consisted of IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab)
- Patient with known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the study
Trial locations and contacts
1 site in 1 country.
About this study
The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient.
The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.
- Conditions
- Circulating Markers, Metastatic Colorectal Cancer
- Being tested
- Blood sampling for free mutant DNA analysis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for free mutant DNA analysisProcedure or surgery
Blood sampling for Patients Treated for Metastatic Colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated for Metastatic Colorectal cancer | Experimental | Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer Receives: Procedure: Blood sampling for free mutant DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from baseline in the number of free mutant DNA in blood
Variation of free mutant DNA kinetic at week 5 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)
Measured: 5 weeks
Secondary outcomes (2)
Difference from baseline in the number of free mutant DNA in blood
Variation of free mutant DNA kinetic at week 3 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)
Measured: 3 weeks
Evaluation of response based on the RECIST 1.1 guideline
sensitivity and specificity of free mutant DNA kinetic at Week 5 (RECIST) to predict tumor progression at 3 months (RECIST)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start18 Jul 2016
- Primary completion10 Aug 2020
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circulating MarkersStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice GANGLOFF, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872779
- Sponsor's protocol ID
- 2015/076/HP
- Acronym
- COCA-MACS
- Status last verified
- Apr 2026
- First submitted
- 16 Aug 2016
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Grancher A, Beaussire-Trouvay L, Vernon V, Dutherage M, Blondin V, Elie C, Bouhier-Leporrier K, Galais MP, Clabaut T, Bignon AL, Parzy A, Gangloff A, Schwarz L, Leveque E, Sabourin JC, Michel P, Vasseur N, Sefrioui D, Gilibert A, Di Fiore F. ctDNA variations according to treatment intensity in first-line metastatic colorectal cancer. Br J Cancer. 2025 May;132(9):814-821. doi: 10.1038/s41416-025-02971-0. Epub 2025 Mar 15.
PubMed 40089635
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02872779
- Acronym / sponsor ID
- COCA-MACS / 2015/076/HP
- Conditions
- Circulating Markers, Metastatic Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 18 Jul 2016 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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.
The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient.
The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated for Metastatic Colorectal cancer | Experimental | Procedure: Blood sampling for free mutant DNA analysisBlood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, age superior to 18 years.
- Histologically confirmed metastatic colorectal adenocarcinoma.
- Measurable disease according to the RECIST 1.1 guideline
- ECOG performance status <3.
- Disease requiring IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) every 14 days
Key exclusion criteria (3 listed)
- Medical history of cancer within 5 years
- Medical contraindication for a treatment consisted of IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab)
- Patient with known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the study
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 sampling for free mutant DNA analysisBlood sampling for Patients Treated for Metastatic Colorectal cancer | Procedure or surgery | Patients Treated for Metastatic Colorectal cancer |
Primary outcome
Difference from baseline in the number of free mutant DNA in blood
Time frame: 5 weeks
Variation of free mutant DNA kinetic at week 5 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)
2 secondary outcomes
Difference from baseline in the number of free mutant DNA in blood
Time frame: 3 weeks
Evaluation of response based on the RECIST 1.1 guideline
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 40089635Grancher A, Beaussire-Trouvay L, Vernon V, Dutherage M, Blondin V, Elie C, Bouhier-Leporrier K, Galais MP, Clabaut T, Bignon AL, Parzy A, Gangloff A, Schwarz L, Leveque E, Sabourin JC, Michel P, Vasseur N, Sefrioui D, Gilibert A, Di Fiore F. ctDNA variations according to treatment intensity in first-line metastatic colorectal cancer. Br J Cancer. 2025 May;132(9):814-821. doi: 10.1038/s41416-025-02971-0. Epub 2025 Mar 15.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Alice GANGLOFF, MD principal investigator
University Hospital, Rouen
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 sampling for free mutant DNA analysis in people with Circulating Markers and Metastatic Colorectal Cancer, run by University Hospital, Rouen 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 7 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: finished, as of the sponsor's last update on 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference from baseline in the number of free mutant DNA in blood (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02872779, which also lists 1 linked publication.
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 16 Apr 2026.