COLOSPOT Study : Assessment by EPISPOT of Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|