Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies

Centre Hospitalier Universitaire de Nīmes1 site in 1 country60 target enrollmentJune 12, 2012

ConditionsColorectal Neoplasms

InterventionsSamples and follow up

Overview

Phase: Not Applicable
Intervention: Samples and follow up
Conditions: Colorectal Neoplasms
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 60
Locations: 1
Primary Endpoint: Ability to maintain the cells isolated from colorectal tumors in culture or 3D collagen matrices and then infect these cells to make them express reporter genes: yes/no.
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this study is to identify and characterize subpopulations of cells with invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.

Detailed Description

Secondary objectives include: * Determine the intrinsic properties essential for the dissemination and chemoresistance of these cells capable of initiating tumors * Identify a "molecular signature" for potential invasiveness and chemoresistance of cells initiating metastases. * Describe the evolution of patients during 24 months of follow up and correlations with observed cellular profiles. * Enrich the tumor bank of the institution.

Registry

clinicaltrials.gov

Start Date

June 12, 2012

End Date

December 31, 2016

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient must have given his/her informed and signed consent
•The patient must be insured or beneficiary of a health insurance plan
•Patient with adenocarcinoma-type colorectal cancer:
•stage III at diagnosis, surgical resection of the primary tumor proposed.
•stage IV at diagnosis, surgical resection of the primary tumor and possibly of metastases proposed.
•Stage IV who have already undergone surgical excision of the primary tumor, and for whom metastasectomy is now proposed.

Exclusion Criteria

•The patient is participating in another study
•The patient is in an exclusion period determined by a previous study
•The patient is under judicial protection, under tutorship or curatorship
•The patient refuses to sign the consent
•It is impossible to correctly inform the patient
•Patients for whom surgical resection of the primary tumor is not considered as an option
•PStage IV at diagnosis, but metastasectomy is not considered as an option
•Patients with positive HIV, Hepatitis B or Hepatitis C serology

Arms & Interventions

30 Patients

Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital. Intervention: Samples and follow up

Intervention: Samples and follow up

Outcomes

Primary Outcomes

Ability to maintain the cells isolated from colorectal tumors in culture or 3D collagen matrices and then infect these cells to make them express reporter genes: yes/no.

Time Frame: Baseline (Day 0)

Secondary Outcomes

Serology Hepatitis B(baseline; day 0)
Serology Hepatitis C(baseline; day 0)
Location of primary tumor(base line; day 0)
Age at diagnosis(baseline, day 0)
Resection proposed: yes/no(baseline, day 0)
Chemotherapy proposed? yes/no(baseline, day 0)
Objective tumoral response to treatment? yes/no(24 months)
Metastases from the outset: Yes / No(baseline, day 0)
Serology HIV(baseline; day 0)
Number of metastases(24 months)
Tumor recurrence: yes/no(24 months)
Vital status(24 months)
Ability to establish tumor xenografts from injected cells: yes/no.(baseline; Day 0)
Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells(baseline; day 0)
Resection performed: yes/no(24 months)
Number of chemotherapy sessions performed(24 months)
Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no(baseline; day 0)
Number of circulating cancer cells per ml blood(baseline; day 0)
Number of surgeries performed(24 months)
World Health Organisation Score(24 months)
Tumor staging(24 months)