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Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01577511
First received: April 12, 2012
Last updated: June 16, 2017
Last verified: June 2017
  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) ]

Secondary Outcome Measures:
  • 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 ]
    right colon, left colon, transverse colon, sigmoid, rectum

  • 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 ]
    living/deceased

  • 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 ]

Biospecimen Retention:   Samples Without DNA
Peroperative blood sample plus primary and metastatic tumor biopsies.

Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: October 2017
Primary Completion Date: October 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jean-François Bourgaux, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Other Identifier: RCB number )
Study First Received: April 12, 2012
Last Updated: June 16, 2017

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

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

ClinicalTrials.gov processed this record on June 23, 2017