Development of a Clinical and Biological Database in Peritoneal Carcinosis (BCB CARCINOSE)

NCT ID: NCT04221464

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2038-02-28

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.

Conditions

Cancer; Peritoneal Carcinosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tumors and blood collection

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

Group Type: EXPERIMENTAL

biological collection

Intervention Type: BIOLOGICAL

Blood samples collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression

Tissues collections

Intervention Type: OTHER

Tumours and not tumours tissues will be collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression

Interventions

biological collection

Blood samples collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression

Intervention Type: BIOLOGICAL

Tissues collections

Tumours and not tumours tissues will be collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François QUENET,MD

Role: STUDY_CHAIR

Institut régional du cancer de Montpellier

Locations

Institut du cancer de Montpellier ICM

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Aurore MOUSSION

Role: CONTACT

aurore.moussion@icm.unicancer.fr

467613100 ext. 33

Facility Contacts

QUENET François,MD

Role: primary

francois.quenet@icm.unicancer.fr

0467612354 ext. 33

Other Identifiers

PROICM 2019-01 BCA

Identifier Type: -

Identifier Source: org_study_id