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Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer

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ClinicalTrials.gov Identifier: NCT01577511
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date April 12, 2012
First Posted Date April 16, 2012
Last Update Posted Date June 21, 2021
Actual Study Start Date June 12, 2012
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2012)
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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 13, 2012)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer
Official Title Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Peroperative blood sample plus primary and metastatic tumor biopsies.
Sampling Method Non-Probability Sample
Study Population Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital.
Condition Colorectal Neoplasms
Intervention Biological: Samples and follow up

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

Follow-up: disease outcomes assessed at 24 months

Study Groups/Cohorts 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: Biological: Samples and follow up
Publications * Grillet F, Bayet E, Villeronce O, Zappia L, Lagerqvist EL, Lunke S, Charafe-Jauffret E, Pham K, Molck C, Rolland N, Bourgaux JF, Prudhomme M, Philippe C, Bravo S, Boyer JC, Canterel-Thouennon L, Taylor GR, Hsu A, Pascussi JM, Hollande F, Pannequin J. Circulating tumour cells from patients with colorectal cancer have cancer stem cell hallmarks in ex vivo culture. Gut. 2017 Oct;66(10):1802-1810. doi: 10.1136/gutjnl-2016-311447. Epub 2016 Jul 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 4, 2014)
60
Original Estimated Enrollment
 (submitted: April 13, 2012)
30
Actual Study Completion Date October 2017
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01577511
Other Study ID Numbers LOCAL/2011/JFB-01
2011-A01141-40 ( Other Identifier: RCB number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor Centre Hospitalier Universitaire de Nīmes
Collaborators Not Provided
Investigators
Principal Investigator: Jean-François Bourgaux, MD Centre Hospitalier Universitaire de Nîmes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date January 2020