NCT04221464

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable cancer

Timeline
142mo left

Started Nov 2019

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Nov 2019Feb 2038

Study Start

First participant enrolled

November 25, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2038

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

8.2 years

First QC Date

January 7, 2020

Last Update Submit

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

EXPERIMENTAL

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 collectionOther: Tissues collections

Interventions

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

Tumors and blood collection

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

Tumors and blood collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • François QUENET,MD

    Institut régional du cancer de Montpellier

    STUDY CHAIR

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

Locations