Development of a Clinical and Biological Database in Rectum Cancer (BCBRectum)
Primary Purpose
Rectal Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological collection
Sponsored by
About this trial
This is an interventional other trial for Rectal Neoplasms focused on measuring Cancer, Colorectal cancer, Biological Specimen Banks
Eligibility Criteria
Inclusion Criteria:
- Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
- Age > 18 years
- Signed informed consent
Exclusion Criteria:
- Patient not affiliated to Social Protection system
- Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
- Patient under guardianship
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 : Paraffin tissue samples (if applicable) collected during pre-therapeutic rectal biopsy Blood samples collected at different times : Before any treatment and Before surgery if the patient received pre-operative radiochemotherapy In parallel to this biological collection, standardized clinical data will be entered into a database
Outcomes
Primary Outcome Measures
Proportion of patients who gave their consent to participate in the study
The proportion of patients who consent to participate in the study among the screened patients
Secondary Outcome Measures
Full Information
NCT ID
NCT04006951
First Posted
July 1, 2019
Last Updated
November 3, 2021
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT04006951
Brief Title
Development of a Clinical and Biological Database in Rectum Cancer
Acronym
BCBRectum
Official Title
Development of a Monocentric and Prospective Clinical and Biological Database in Rectum Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2014 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
December 2026 (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
A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Rectum Cancer.
Detailed Description
In France, colorectal cancer is the second major cause of cancer-related death with 17 000 cases per year. Rectal carcinoma represents 40% of colorectal cancers.
Locally advanced rectal carcinoma raises the issue of both the oncological control, local and general, and the therapeutic morbidity. Currently, pre-operative radiochemotherapy associated with radical proctectomy (TME) is the standard treatment. Radiochemotherapy improves the local control but with enhanced postoperative morbidity and poor functional results.
Moreover, some patients have no downstaging (around 1/3) and the metastatic risk remains about 30%.
Then, compliance to adjuvant chemotherapy is generally poor after radical proctectomy.
Tumor response to preoperative treatment is the major prognostic factor which reveals tumor aggressiveness. Nevertheless, at present, there are no predictive markers of tumor response.
Progresses in rectal cancer management are related to sharing biological and clinical resources with scientific community.
A clinical and biological collection will allow to :
develop research programs on predictive markers to pre-operative radiochemotherapy or prognostics factors to disease recurrence
optimize diagnostic and follow-up tests
develop new biomarkers to improve patient's therapeutic management
In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection biomedical research dedicated to the tissular and blood samples of patients with colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Cancer, Colorectal cancer, Biological Specimen Banks
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological collection
Arm Type
Experimental
Arm Description
For all the patients include in the study :
Paraffin tissue samples (if applicable) collected during pre-therapeutic rectal biopsy
Blood samples collected at different times : Before any treatment and Before surgery if the patient received pre-operative radiochemotherapy
In parallel to this biological collection, standardized clinical data will be entered into a database
Intervention Type
Other
Intervention Name(s)
Biological collection
Intervention Description
Blood samples are collected at different times :
Before any treatment
After pre-operative radiochemotherapy and before surgery (if applicable)
Primary Outcome Measure Information:
Title
Proportion of patients who gave their consent to participate in the study
Description
The proportion of patients who consent to participate in the study among the screened patients
Time Frame
Until the study completion : 66 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic cancer treatment or radiotherapy or surgery)
Age > 18 years
Signed informed consent
Exclusion Criteria:
Patient not affiliated to Social Protection system
Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
Patient under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BLEUSE Jean-Pierre, MD
Phone
4 67 61 31 00
Ext
+33
Email
jean-pierre.bleuse@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROUANET Philippe, MD-PhD
Organizational Affiliation
Institut régional du Cancer Montpellier
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
Phone
00467613102
Email
jean-pierre.bleuse@icm.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of a Clinical and Biological Database in Rectum Cancer
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