Development of a Clinical and Biological Database in Peritoneal Carcinosis (BCB CARCINOSE) (BCB)
Primary Purpose
Cancer, Peritoneal Carcinosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological collection
Tissues collections
Sponsored by
About this trial
This is an interventional other trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient over the age of 18;
- Patient managed for peritoneal carcinosis : digestives origins (pancreatic, gastroesophageal junction, colorectal, bowel) or peritoneum cancer
- Patient eligible for a peritoneal carcinosis treatment : at least one (or more) surgery (s) ;chemotherapy or any treatment for this disease
- Patient agree will all study procedure : biological samples & tissues samples
- Patient giving 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
- The level of French is insufficient to consent to the study and to response to the questionnaires
- Patient under guardianship
- Pregnancy ou breast-feeding women
- Patient treated in case of an emergency
Sites / Locations
- Institut du cancer de Montpellier ICMRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tumors and blood collection
Arm Description
For all the patients include in the study : Blood samples will be collected at different times : before any treatment, at every surgery, one month after any surgery, at progression. Tumours and not tumours tissues will be collected at different times : Before any surgery, one month after any surgery In parallel to this biological collection, standardized clinical data will be entered into a database treatment, at every surgery
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
NCT04221464
First Posted
January 7, 2020
Last Updated
January 7, 2022
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT04221464
Brief Title
Development of a Clinical and Biological Database in Peritoneal Carcinosis (BCB CARCINOSE)
Acronym
BCB
Official Title
Development of a Clinical and Biological Database Monocentric and Prospective in Peritoneal Carcinosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2029 (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
The creation of a prospective clinical-biological base dedicated to peritoneal carcinosis must therefore be able to serve as a support for this essential search for transfer.
Detailed Description
The main objective is to improve the knowledge of carcinosis mechanisms to develop a specific treatment.
That's why this blood collection and tissue collection is very important for the future, these collection will be permitted to the scientists to develop a research specially for carcinosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Peritoneal Carcinosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tumors and blood collection
Arm Type
Experimental
Arm Description
For all the patients include in the study :
Blood samples will be collected at different times : before any treatment, at every surgery, one month after any surgery, at progression.
Tumours and not tumours tissues will be collected at different times : Before any surgery, one month after any surgery
In parallel to this biological collection, standardized clinical data will be entered into a database treatment, at every surgery
Intervention Type
Biological
Intervention Name(s)
biological collection
Intervention Description
Blood samples collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression
Intervention Type
Other
Intervention Name(s)
Tissues collections
Intervention Description
Tumours and not tumours tissues will be collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression
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: 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient over the age of 18;
Patient managed for peritoneal carcinosis : digestives origins (pancreatic, gastroesophageal junction, colorectal, bowel) or peritoneum cancer
Patient eligible for a peritoneal carcinosis treatment : at least one (or more) surgery (s) ;chemotherapy or any treatment for this disease
Patient agree will all study procedure : biological samples & tissues samples
Patient giving 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
The level of French is insufficient to consent to the study and to response to the questionnaires
Patient under guardianship
Pregnancy ou breast-feeding women
Patient treated in case of an emergency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BLEUSE Jean-Pierre,MD
Phone
467613100
Ext
33
Email
jean-pierre.bleuse@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
QUENET François,MD
Organizational Affiliation
Institut régional du cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut du cancer de Montpellier ICM
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
QUENET François,MD
Phone
0467612354
Ext
33
Email
francois.quenet@icm.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
Development of a Clinical and Biological Database in Peritoneal Carcinosis (BCB CARCINOSE)
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