Clinical trial · Interventional
COLOSPOT Study : Assessment by EPISPOT of Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
Assessment by EPISPOT of Circulating Tumor Cells as an Early Predictive Marker of Response to Chemotherapy and Targeted Therapy in Patients With Metastatic Colorectal Cancer in First Line of Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. During these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients. However, the choice of the therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers of their efficiency. Indeed, only the mutation of the k-ras oncogene is a predictive factor of non-efficacy of the anti-EGFR antibodies. It is thus crucial to identify new biomarkers to propose the best personalized 1rst line therapeutic sequence. One idea would be to enumerate and characterize the circulating tumor cells (CTC) which, as it has been described in a recent study realized by Cohen et al. in patients with metastatic colorectal cancer, would give us an early evaluation of the therapeutic efficiency. In this context, the investigators have developed an innovative technology, the EPISPOT assay (patent of the University Medical Center of Montpellier), that allows the detection \& characterization of viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the breast and prostate cancer. Thus, the investigators would like to perform a prospective study on a cohort of patients with metastatic colorectal cancer to confirm, with this technology, the predictive value of CTC count for the efficacy of the treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood analysis by EPISPOT and Cellsearch | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CTC assay
- description
- Detection \& characterization of viable CTC in the peripheral blood.
- interventionNames
- Other: Blood analysis by EPISPOT and Cellsearch
Primary outcomes (1)
- measure
- Predictive value of the CTC on the Progression Free Survival
- timeFrame
- Duration study 3 years
- description
- The primary outcome aims to evaluate the predictive value of the early progression of the CTC performed with the EPISPOT assay on the PFS in a cohort of patients treated with 5-FU, IRNOTECAN et AVASTIN (FOLFIRI or XELIRI-AVASTIN) in 1rst line of metastatic colorectal cancer. The progression disease is assessed based on imagery techniques.
Secondary outcomes (4)
- measure
- Prognostic value of the CTC detected by EPISPOT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Colon or rectum adenocarcinoma (based on the histology) * Visceral metastases (synchronous and/or metachronous) * Metastatic disease measurable with the RECIST 1.1 criteria * WHO performance status 0, 1 or 2 * Life expectancy\>3 months when starting the treatment * Chemotherapy in metastatic 1rst line combining a protocol of conventional chemotherapy combining 5-FU and IRINOTECAN (FOLFIRI, XELIRI) associated with bevacizumab * Follow-up of at least one year * Collection of the written consent * Social security affiliation Exclusion Criteria: * 2nd line chemotherapy and beyond * History of other cancers considered not cured * Active and progressive infection or other serious disease that may not allow the patient to receive the treatment * refusal to participate * Patient unable to express his consent * Pregnant women * Patient unable to be followed-up for at least one year * Current participation to another clinical trial * Patients under guardianship * Vulnerable people protected by the law
References
Publications (2)
- RESULTMazard T, Cayrefourcq L, Perriard F, Senellart H, Linot B, de la Fouchardiere C, Terrebonne E, Francois E, Obled S, Guimbaud R, Mineur L, Fonck M, Daures JP, Ychou M, Assenat E, Alix-Panabieres C. Clinical Relevance of Viable Circulating Tumor Cells in Patients with Metastatic Colorectal Cancer: The COLOSPOT Prospective Study. Cancers (Basel). 2021 Jun 13;13(12):2966. doi: 10.3390/cancers13122966. PMID 34199250
- DERIVEDCayrefourcq L, Thomas F, Mazard T, Assenat E, Assou S, Alix-Panabieres C. Selective treatment pressure in colon cancer drives the molecular profile of resistant circulating tumor cell clones. Mol Cancer. 2021 Feb 8;20(1):30. doi: 10.1186/s12943-021-01326-6. PMID 33557844