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

January 7, 2022 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who gave their consent to participate in the study
Time Frame: Until the study completion: 4 years
The proportion of patients who consent to participate in the study among the screened patients
Until the study completion: 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: QUENET François,MD, Institut Regional du Cancer de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2019

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2029

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2019-01 BCA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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