Overview

This trial is active, not recruiting.

Condition colorectal neoplasms
Treatment samples and follow up
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date June 2012
End date October 2015
Trial size 60 participants
Trial identifier NCT01577511, 2011-A01141-40, LOCAL/2011/JFB-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital. Intervention: Samples and follow up
samples and follow up
Samples: Peroperative blood sample plus primary and metastatic tumor biopsies. Follow-up: disease outcomes assessed at 24 months

Primary Outcomes

Measure
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

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies
Principal investigator Jean-François Bourgaux, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.