Metastatic Colorectal CancerCoca-ColonNCT01212510
Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer
A study testing Blood sampling in people with Metastatic Colorectal Cancer, run by University Hospital, Rouen at 4 sites in France.
Trial summary
The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2010to Jul 2016
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has Stage IV colorectal adenocarcinoma histologically proved
- Patient has at least one measurable lesion
- Patient has performance status 0-2 on the WHO performance scale
- Patient is male or female, and > 18 years of age
- Patient has agree to participate by giving written informed consent
Who cannot join
- Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre François Baclesse
Caen, 14000
University Hospital
Caen, 14000
Centre Frédéric Joliot
Rouen, 76000
University Hospital
Rouen, 76000
About this study
The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.
Read the detailed description
Prospective cohort study of patients treated with systemic chemotherapy for unresectable metastatic colorectal cancer. The chemotherapy monitoring is currently based on radiological evaluation (RECIST criteria) and clinical evaluation. Circulating markers as CEA, free mutant DNA, CTC represent an alternative approach. A previous study on usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer has been published (J Clin Oncol 2008;26:3681-6). The present study is designed to validate the previous data. The secondary purpose is to evaluate variations of free mutant DNA and CTC during the chemotherapy. Patients will be included prospectively in 4 centers in Normandy. All systemic chemotherapy and biotherapy validate in this clinical situation by the French National Cancer Institute (INCa) is accepted. Evaluation of response based on RECIST criteria will be performed every 3 months. Blood samples for CEA and CA 19-9 levels will be performed every courses of chemotherapy during first 3 months. Blood samples for detection of free mutant DNA and CTC will be performed at day 1 and 42 of chemotherapy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Blood sampling
- Keywords
- metastatic colorectal cancer, circulating tumor markers, circulating tumor cell, circulating tumor DNA, marker's kinetic
- Medical subject headings
- Colorectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA
| Study group | Role | What they receive |
|---|---|---|
| Tumor markers | Other | measurement of tumor markers ( blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA ) Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of tumor progression
sensitivity and specificity of CEA kinetic to predict tumor progression at 3 months (RECIST)
Measured: 3 months
Secondary outcomes (1)
Prediction of tumor response
sensitivity and specificity of CEA kinetic to predict tumor response 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 posted30 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2016
- Study completionJul 2016
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre MICHEL, Pr, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212510
- Sponsor's protocol ID
- 2009/170/HP
- Acronym
- Coca-Colon
- Status last verified
- Aug 2016
- First submitted
- 29 Sep 2010
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sefrioui D, Beaussire L, Gillibert A, Blanchard F, Toure E, Bazille C, Perdrix A, Ziegler F, Gangloff A, Hassine M, Elie C, Bignon AL, Parzy A, Gomez P, Thill C, Clatot F, Sabourin JC, Frebourg T, Benichou J, Bouhier-Leporrier K, Gallais MP, Sarafan-Vasseur N, Michel P, Di Fiore F. CEA, CA19-9, circulating DNA and circulating tumour cell kinetics in patients treated for metastatic colorectal cancer (mCRC). Br J Cancer. 2021 Aug;125(5):725-733. doi: 10.1038/s41416-021-01431-9. Epub 2021 Jun 10.
PubMed 34112948
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01212510
- Acronym / sponsor ID
- Coca-Colon / 2009/170/HP
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer, circulating tumor markers, circulating tumor cell, circulating tumor DNA, marker's kinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Sep 2010 (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 primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.
Detailed description
Prospective cohort study of patients treated with systemic chemotherapy for unresectable metastatic colorectal cancer. The chemotherapy monitoring is currently based on radiological evaluation (RECIST criteria) and clinical evaluation. Circulating markers as CEA, free mutant DNA, CTC represent an alternative approach. A previous study on usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer has been published (J Clin Oncol 2008;26:3681-6). The present study is designed to validate the previous data. The secondary purpose is to evaluate variations of free mutant DNA and CTC during the chemotherapy. Patients will be included prospectively in 4 centers in Normandy. All systemic chemotherapy and biotherapy validate in this clinical situation by the French National Cancer Institute (INCa) is accepted. Evaluation of response based on RECIST criteria will be performed every 3 months. Blood samples for CEA and CA 19-9 levels will be performed every courses of chemotherapy during first 3 months. Blood samples for detection of free mutant DNA and CTC will be performed at day 1 and 42 of chemotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor markers | Other | Other: Blood samplingmeasurement of tumor markers ( blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA ) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has Stage IV colorectal adenocarcinoma histologically proved
- Patient has at least one measurable lesion
- Patient has performance status 0-2 on the WHO performance scale
- Patient is male or female, and > 18 years of age
- Patient has agree to participate by giving written informed consent
Key exclusion criteria (1 listed)
- Patient has known psychiatric or substance abuse disorders that would 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 samplingblood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA | Other | Tumor markers |
Primary outcome
Prediction of tumor progression
Time frame: 3 months
sensitivity and specificity of CEA kinetic to predict tumor progression at 3 months (RECIST)
1 secondary outcome
Prediction of tumor response
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 17 Aug 2016.
- Derived from this study: PubMed 34112948Sefrioui D, Beaussire L, Gillibert A, Blanchard F, Toure E, Bazille C, Perdrix A, Ziegler F, Gangloff A, Hassine M, Elie C, Bignon AL, Parzy A, Gomez P, Thill C, Clatot F, Sabourin JC, Frebourg T, Benichou J, Bouhier-Leporrier K, Gallais MP, Sarafan-Vasseur N, Michel P, Di Fiore F. CEA, CA19-9, circulating DNA and circulating tumour cell kinetics in patients treated for metastatic colorectal cancer (mCRC). Br J Cancer. 2021 Aug;125(5):725-733. doi: 10.1038/s41416-021-01431-9. Epub 2021 Jun 10.
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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.
Pierre MICHEL, Pr principal investigator
UH Rouen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Metastatic Colorectal Cancer, run by University Hospital, Rouen at 4 sites 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 5 inclusion and 1 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 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Prediction of tumor progression (time frame: 3 months). 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 NCT01212510, 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 17 Aug 2016.