Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer

This study is currently recruiting participants.
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01577511
First received: April 12, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
Biological: Samples and follow up

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serology HIV [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • Serology Hepatitis B [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • Serology Hepatitis C [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • Location of primary tumor [ Time Frame: base line; day 0 ] [ Designated as safety issue: No ]
    right colon, left colon, transverse colon, sigmoid, rectum

  • Age at diagnosis [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
  • Metastases from the outset: Yes / No [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
  • Resection proposed: yes/no [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
  • Chemotherapy proposed? yes/no [ Time Frame: baseline, day 0 ] [ Designated as safety issue: No ]
  • Number of metastases [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Resection performed: yes/no [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of chemotherapy sessions performed [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Objective tumoral response to treatment? yes/no [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Tumor recurrence: yes/no [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Vital status [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    living/deceased

  • Ability to establish tumor xenografts from injected cells: yes/no. [ Time Frame: baseline; Day 0 ] [ Designated as safety issue: No ]
  • Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • World Health Organisation Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Tumor staging [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of surgeries performed [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of circulating cancer cells per ml blood [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Peroperative blood sample plus primary and metastatic tumor biopsies.


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned 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

Biological: Samples and follow up

Samples: Peroperative blood sample plus primary and metastatic tumor biopsies.

Follow-up: disease outcomes assessed at 24 months


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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577511

Contacts
Contact: Jean François Bourgaux, MD +33.(0)4.66.68.35.72 jean.francois.bourgaux@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Jean François Bourgaux, MD         
Sub-Investigator: Frédéric Hollande, MD         
Sub-Investigator: Philippe Pouderoux, MD PhD         
Sub-Investigator: Michel Prudhomme, MD PhD         
Sub-Investigator: Sylvain Laporte, MD         
Sub-Investigator: Jean-Marc Pascussi, MD         
Sub-Investigator: Julie Pannequin, MD         
Sub-Investigator: Caillo Ludovic, MD         
Sub-Investigator: Pascal Roger, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jean-François Bourgaux, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01577511     History of Changes
Other Study ID Numbers: LOCAL/2011/JFB-01, 2011-A01141-40
Study First Received: April 12, 2012
Last Updated: March 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
invasive potential
molecular characterisation of circulating cells

Additional relevant MeSH terms:
Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014