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

Cancer Clinical Trial

— BCB  

Official title:

Development of a Clinical and Biological Database Monocentric and Prospective in Peritoneal Carcinosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04221464
• Other study ID #: PROICM 2019-01 BCA
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: November 2029

Study information

• Verified date: January 2022
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: BLEUSE Jean-Pierre,MD
• Phone: 467613100
• Email: jean-pierre.bleuse[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2029
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Carcinoma
• Peritoneal Carcinosis

Intervention

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

Other:
• 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

Locations

Country	Name	City	State
France	Institut du cancer de Montpellier ICM	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Until the study completion: 4 years