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

August 3, 2020 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • Medical Oncology, CHU St Eloi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: CTC assay
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration study 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration study 3 years
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.
Duration study 3 years
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®.
Duration study 3 years
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.
Duration study 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Roche Pharma AG
National Cancer Institute, France
Direction Générale de l'Offre de Soins

Investigators

  • Study Director: Panabieres Catherine, PhD, UH Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2012

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (ESTIMATE)

May 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8748
  • ID-RCB 2011-A01130-41 (OTHER: Afssaps)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Colorectal Cancer

Clinical Trials on Blood analysis by EPISPOT and Cellsearch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe