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Completed

NCT Number: NCT01577511

Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samples and follow up

Biological

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

Follow-up: disease outcomes assessed at 24 months

Primary outcomes

  1. 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

  1. Serology HIV

    Time frame: baseline; day 0

  2. Serology Hepatitis B

    Time frame: baseline; day 0

  3. Serology Hepatitis C

    Time frame: baseline; day 0

  4. Location of primary tumor

    Time frame: base line; day 0

    right colon, left colon, transverse colon, sigmoid, rectum

  5. Age at diagnosis

    Time frame: baseline, day 0

  6. Metastases from the outset: Yes / No

    Time frame: baseline, day 0

  7. Resection proposed: yes/no

    Time frame: baseline, day 0

  8. Chemotherapy proposed? yes/no

    Time frame: baseline, day 0

  9. Number of metastases

    Time frame: 24 months

  10. Resection performed: yes/no

    Time frame: 24 months

  11. Number of chemotherapy sessions performed

    Time frame: 24 months

  12. Objective tumoral response to treatment? yes/no

    Time frame: 24 months

  13. Tumor recurrence: yes/no

    Time frame: 24 months

  14. Vital status

    Time frame: 24 months

    living/deceased

  15. Ability to establish tumor xenografts from injected cells: yes/no.

    Time frame: baseline; Day 0

  16. Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no

    Time frame: baseline; day 0

  17. Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells

    Time frame: baseline; day 0

  18. World Health Organisation Score

    Time frame: 24 months

  19. Tumor staging

    Time frame: 24 months

  20. Number of surgeries performed

    Time frame: 24 months

  21. Number of circulating cancer cells per ml blood

    Time frame: baseline; day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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