COLOSPOT Study : Assessment by EPISPOT of Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01596790|
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : May 11, 2012
Last Update Posted : December 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Other: Blood analysis by EPISPOT and Cellsearch||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||April 2016|
Detection & characterization of viable CTC in the peripheral blood.
Other: Blood analysis by EPISPOT and Cellsearch
For each patient, we will perform a counting of CTC before chemotherapy and then at different time points after chemotherapy, using both technologies: EPISPOT and CellSearch®.For the EPISPOT, we will need 15 mL of peripheral blood on EDTA tubes. For each patient, five blood samples will be done: D0, D14, D28, D42 and D56. These different time points will help us to determine when the best moment is for the evaluation of the CTC with this technology.For the CellSearch®, we will need 10 mL of peripheral blood on a specific CellSave tube. Only two samples will be perform: D0 and D28 because Cohen et al. (2008) reported that the best appropriated moment to appreciate the CTC progression is between 3 and 5 weeks after the initiation of the treatment.
- Predictive value of the CTC on the Progression Free Survival [ Time Frame: Duration study 3 years ]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.
- Prognostic value of the CTC detected by EPISPOT [ Time Frame: Duration study 3 years ]For the EPISPOT assay, 15 mL of peripheral blood will be collected on EDTA tubes. For each patient, 5 blood samples will be collected: at D0, D14, D28, D42 and D56.
- Predictive value of the CTC on the overall survival [ Time Frame: Duration study 3 years ]The overall survival will be defined as the time between the beginning of the chemotherapy and death.
- VEGF expressions by the CTC [ Time Frame: Duration study 3 years ]To evaluate the VEGF expression by the CTC with both technologies, the EPISPOT and the CellSearch®.
- Comparison of the results with the CellSearch system vs EPISPOT [ Time Frame: Duration study 3 years ]
For the Cellsearch assay, 10 mL of peripheral blood will be collected on specific tubes. Only 2 samples will be performed: at D0 and D28.
The Cellsearch and EPISPOT techniques will be performed in parallel and then compared.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596790
|Contact: Panabieres Catherine, PHD||33 4 67 33 05 firstname.lastname@example.org|
|Medical Oncology, CHU St Eloi||Recruiting|
|Montpellier, France, 34090|
|Contact: YCHOU Marc, MD +33 4 67 33 01 37 email@example.com|
|Contact: PANABIERES Catherine, PhD + 33 4 67 33 05 05 firstname.lastname@example.org|
|Principal Investigator: Marc YCHOU, MD|
|Sub-Investigator: Eric ASSENAT, MD|
|Study Director:||Panabieres Catherine, PhD||UH Montpellier|