COLOSPOT Study : Assessment by EPISPOT of Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer

NCT ID: NCT01596790

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2019-09-30

Brief Summary

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.

Detailed Description

In the aim to study a homogeneous cohort of patients, the investigators will only recruit patients in first line of treatment and treated by 5-FU (IV), IRINOTECAN et BEVACIZUMAB combination.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CTC assay

Detection \& characterization of viable CTC in the peripheral blood.

Group Type: OTHER

Blood analysis by EPISPOT and Cellsearch

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role: collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Panabieres Catherine, PhD

Role: STUDY_DIRECTOR

UH Montpellier

Locations

Medical Oncology, CHU St Eloi

Montpellier, , France

Countries

France

References

Cayrefourcq 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.

Reference Type: DERIVED

PMID: 33557844 (View on PubMed)

Other Identifiers

ID-RCB 2011-A01130-41

Identifier Type: OTHER

Identifier Source: secondary_id

8748

Identifier Type: -

Identifier Source: org_study_id