Development of Clinical and Biological Database in Colorectal Cancer (CIRCUS)
Primary Purpose
Metastatic Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional other trial for Metastatic Colon Cancer focused on measuring colon cancer, circulating tumoral cells
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 18 years
- Histological evidence of metastatic colorectal cancer
- Naïve patients receiving chemotherapy at the metastatic stage or who have received adjuvant chemotherapy for more than 6 months
- Obtain signed informed consent prior to any specific preselection procedure.
Exclusion Criteria:
- History of Chemotherapy Treatment and / or Targeted Therapy for Metastatic Colorectal Cancer
- Breastfeeding or pregnant woman
- Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons
- Any severe or unstable medical, psychiatric or other condition that may interfere with the patient's safety, consent or compliance with the study protocol
- Patient not benefiting from a social security scheme
Sites / Locations
- ICM Val d'AurelleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biological collection
Arm Description
For all the patients include in the study : - Blood samples collected at before any treatment In parallel to this biological collection, standardized clinical data will be entered into a database
Outcomes
Primary Outcome Measures
Isolation of circulating tumoral cells
among 100 patients, to isolate at least 10 cell-lines to show the heterogeneity between patients
Secondary Outcome Measures
Full Information
NCT ID
NCT04186117
First Posted
December 2, 2019
Last Updated
November 3, 2021
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT04186117
Brief Title
Development of Clinical and Biological Database in Colorectal Cancer
Acronym
CIRCUS
Official Title
Clinical and Biological Evaluation to Caracterize Circulating Tumoral Cells in Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2016 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Creation of circulating cancer cell-lines and caracterisation of these cell-lines which will be collected before any treatment in patients with metastatic colon adenocarcinoma
Detailed Description
In the light of literature data, it becomes crucial to develop models for studying the functionality of CTCs. In this context, xenograft models in nude mice have recently been described9,10. Establishing cell lines to allow CTC amplification to have enough material to work is an attractive approach. Some recent studies have demonstrated the feasibility of establishing such tools in breast or prostate cancer, 11, 12 but no studies have been done for colorectal cancer. Thus on the basis of the hypothesis that circulating tumor cells could be, or at least contain, cancerous stem cells, we propose to isolate them under conditions that promote their survival in order to characterize them in the particular context of colorectal cancer.
If CTCs consist at least in part of CSCs, they should survive in an environment favorable to the culture of these cells. It is for this reason that purified CTCs will be seeded in plaques that prevent cell adhesion and in a serum-free medium but including growth factors (M12) under hypoxia conditions to approximate their original context. The ability of these cells to form spheres will be observed under these conditions.
In this context, the team of the Institute of Functional Genomics of Montpellier are the first, to have developed and characterized three lines of CTC from blood samples of patients with metastatic colon cancer (Grillet F. and al; submitted for publication). In addition to the characterization of these rare cells and the decryption of some of the mechanisms involved in tumor dissemination, this tool is very valuable for the clinic. Indeed, it could help the establishment of personalized medicine to test quickly (less than 3 weeks) on the CTC of the patient, the effectiveness of conventional treatments but also new drugs included in clinical protocols. For the basic research part, this line will help us to characterize these cells because the number is no longer a limiting factor, the main objective now being to obtain more lines from a blood sample from patients with different profiles by optimizing cell culture conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colon Cancer
Keywords
colon cancer, circulating tumoral cells
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological collection
Arm Type
Experimental
Arm Description
For all the patients include in the study :
- Blood samples collected at before any treatment
In parallel to this biological collection, standardized clinical data will be entered into a database
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Blood sample before any treatment
Primary Outcome Measure Information:
Title
Isolation of circulating tumoral cells
Description
among 100 patients, to isolate at least 10 cell-lines to show the heterogeneity between patients
Time Frame
Until the study completion : 54 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 18 years
Histological evidence of metastatic colorectal cancer
Naïve patients receiving chemotherapy at the metastatic stage or who have received adjuvant chemotherapy for more than 6 months
Obtain signed informed consent prior to any specific preselection procedure.
Exclusion Criteria:
History of Chemotherapy Treatment and / or Targeted Therapy for Metastatic Colorectal Cancer
Breastfeeding or pregnant woman
Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons
Any severe or unstable medical, psychiatric or other condition that may interfere with the patient's safety, consent or compliance with the study protocol
Patient not benefiting from a social security scheme
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre BLEUSE
Phone
0467613102
Email
DRCI-icm105@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle SAMALIN, MD
Organizational Affiliation
Institut Régional du Cancer de Montpellier (ICM)
Official's Role
Study Chair
Facility Information:
Facility Name
ICM Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BLEUSE Jean-pierre, MD
Phone
00467613102
Email
jean-pierre.bleuse@icm.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
Development of Clinical and Biological Database in Colorectal Cancer
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