Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577511
• Other study ID #: LOCAL/2011/JFB-01
• Secondary ID: 2011-A01141-40
• Status: Completed
• Start date: June 12, 2012
• Est. completion date: October 2017

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Baseline (Day 0)
Secondary	Serology HIV		baseline; day 0
Secondary	Serology Hepatitis B		baseline; day 0
Secondary	Serology Hepatitis C		baseline; day 0
Secondary	Location of primary tumor	right colon, left colon, transverse colon, sigmoid, rectum	base line; day 0
Secondary	Age at diagnosis		baseline, day 0
Secondary	Metastases from the outset: Yes / No		baseline, day 0
Secondary	Resection proposed: yes/no		baseline, day 0
Secondary	Chemotherapy proposed? yes/no		baseline, day 0
Secondary	Number of metastases		24 months
Secondary	Resection performed: yes/no		24 months
Secondary	Number of chemotherapy sessions performed		24 months
Secondary	Objective tumoral response to treatment? yes/no		24 months
Secondary	Tumor recurrence: yes/no		24 months
Secondary	Vital status	living/deceased	24 months
Secondary	Ability to establish tumor xenografts from injected cells: yes/no.		baseline; Day 0
Secondary	Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no		baseline; day 0
Secondary	Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells		baseline; day 0
Secondary	World Health Organisation Score		24 months
Secondary	Tumor staging		24 months
Secondary	Number of surgeries performed		24 months
Secondary	Number of circulating cancer cells per ml blood		baseline; day 0