Clinical trial NCT01577511: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: invasive potential
molecular characterisation of circulating cells
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital.

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.

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

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.
timeFrame: Baseline (Day 0)
Secondary outcomes:
measure: Serology HIV
timeFrame: baseline; day 0
measure: Serology Hepatitis B
timeFrame: baseline; day 0
measure: Serology Hepatitis C
timeFrame: baseline; day 0
measure: Location of primary tumor
timeFrame: base line; day 0
measure: Age at diagnosis
timeFrame: baseline, day 0
measure: Metastases from the outset: Yes / No
timeFrame: baseline, day 0
measure: Resection proposed: yes/no
timeFrame: baseline, day 0
measure: Chemotherapy proposed? yes/no
timeFrame: baseline, day 0
measure: Number of metastases
timeFrame: 24 months
measure: Resection performed: yes/no
timeFrame: 24 months
measure: Number of chemotherapy sessions performed
timeFrame: 24 months
measure: Objective tumoral response to treatment? yes/no
timeFrame: 24 months
measure: Tumor recurrence: yes/no
timeFrame: 24 months
measure: Vital status
timeFrame: 24 months
measure: Ability to establish tumor xenografts from injected cells: yes/no.
timeFrame: baseline; Day 0
measure: Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no
timeFrame: baseline; day 0
measure: Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells
timeFrame: baseline; day 0
measure: World Health Organisation Score
timeFrame: 24 months
measure: Tumor staging
timeFrame: 24 months
measure: Number of surgeries performed
timeFrame: 24 months
measure: Number of circulating cancer cells per ml blood
timeFrame: baseline; day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-François Bourgaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.