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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Treated for Metastatic Colorectal cancer | Experimental | Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling for free mutant DNA analysis | Procedure | Blood sampling for Patients Treated for Metastatic Colorectal cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 weeks |
| Evaluation of response based on the RECIST 1.1 guideline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice GANGLOFF, MD | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital | Rouen | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40089635 | Result | 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. |
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sensitivity and specificity of free mutant DNA kinetic at Week 5 (RECIST) to predict tumor progression at 3 months (RECIST) |
| 3 Months |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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