Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer
- Conditions
- Colorectal Neoplasms
- Interventions
- Biological: Samples and follow up
- Registration Number
- NCT01577511
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 30 Patients Samples and follow up Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital. Intervention: Samples and follow up
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no baseline; day 0 Number of circulating cancer cells per ml blood baseline; day 0 Serology HIV baseline; day 0 Serology Hepatitis C baseline; day 0 Location of primary tumor base line; day 0 right colon, left colon, transverse colon, sigmoid, rectum
Age at diagnosis baseline, day 0 Resection proposed: yes/no baseline, day 0 Chemotherapy proposed? yes/no baseline, day 0 Objective tumoral response to treatment? yes/no 24 months Number of metastases 24 months Tumor recurrence: yes/no 24 months Vital status 24 months living/deceased
Ability to establish tumor xenografts from injected cells: yes/no. baseline; Day 0 Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells baseline; day 0 Serology Hepatitis B baseline; day 0 Metastases from the outset: Yes / No baseline, day 0 Resection performed: yes/no 24 months Number of chemotherapy sessions performed 24 months Number of surgeries performed 24 months World Health Organisation Score 24 months Tumor staging 24 months
Trial Locations
- Locations (1)
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, Gard, France