Development of a Clinical and Biological Database in Peritoneal Carcinosis (BCB CARCINOSE)
BCB
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Nov 2019
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2019
CompletedFirst Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2038
February 12, 2025
February 1, 2025
8.2 years
January 7, 2020
February 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Tumors and blood collection
EXPERIMENTALFor 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
Interventions
Blood samples collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression
Tumours and not tumours tissues will be collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut du cancer de Montpellier ICM
Montpellier, 34298, France
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
François QUENET,MD
Institut régional du cancer de Montpellier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 9, 2020
Study Start
November 25, 2019
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2038
Last Updated
February 12, 2025
Record last verified: 2025-02