Pleural Carcinomatosis Tissue Banking (TICP)

February 27, 2024 updated by: Hospices Civils de Lyon

Creation of a Pleural Carcinomatosis Tissue Bank

Malignant pleural effusion is a common evolution of various cancers and is associated with poor prognosis and quality of life. About 28% of patients with primary malignancy will develop pleural metastasis. Malignant pleural effusion mostly occurs in lung, breast, ovarian and gastric cancers. Median survival ranges from 3 to 13 months according to primary malignancy. Currently, the therapeutic approach is mainly palliative with videothoracoscopic talc pleurodesis or indwelling pleural catheters insertion eventually associated with systemic chemotherapy if patient's general condition allows.

In a early-disseminated tumor cells profile, metastatic cells can accumulate alterations at a distant site and have a different profil from the original tumor cells. Metastatic cells can also accumulate alterations in the course if systemic treatments. Consequently, they may respond differently to drugs.

Recently, EGFR mutations and ALK status discordance between primary tumors and pleural metastases have been demonstrated in a significant portion of lung adenocarcinomas. These studies, realized on malignant pleural effusion isolated cells, enabled us to hypothesize a possible intratumoral heterogeneity within pleural metastases, but no study has been carried out on pleural tissue.

Our aim is to create a biocollection with tissues from pleural carcinomatosis in order to subsequently allow multiomics and bioinformatics analyzes and to characterize a possible intratumoral heterogeneity in pleural metastasis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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 Contact Backup

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 to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study concerns adult patients with pleural metastasis eligible for a surgical exploration of the pleura

Description

Inclusion Criteria:

  • Male or female over 18 years old
  • Malignant pleural effusion with or without prior histological or cytological diagnosis
  • Patient eligible for a pleural biopsy for diagnostic purposes and validated in a multidisciplinary consultation meeting
  • Having given their free and informed writing consent
  • Affiliated to a social security system or assimilated

Exclusion Criteria:

  • Malignant pleural mesothelioma
  • Contraindication to general anesthesia
  • Pregnant or breastfeeding woman, or is of child bearing potential and who did not agree to use highly effective methods of birth control throughout the study.
  • Patient participating in a interventional study likely to interfere with this study
  • Patient benefiting from a legal protection measure (guardianship or curatorship)

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
malignant pleural effusion
Patients with malignant pleural effusion who underwent pleural biopsies and blood tests under general anesthesia
Genetic: Conserving routinely performed pleural biopsies in our biological resources center to realize multiomics and bioinformatics analyzes secondarily
Interventions will consist of a diagnostic and symptomatic videothoracoscopy in patients with pleural metastasis under general anesthesia, as part of a standard of care procedure. Fragments of these pleural biopsies (one for routine diagnosis and two for scientific purposes) will enrich the biocollection. Five blood samples will be taken at the time of surgery (3 to 5 ml / tube). These biological samples will be stored in the HCL CRB tumor bank. At the same time, patient demographic data will be collected and anonymized. In the long term, the biological material will be used by IARC for carrying out multi-omics and bioinformatics analyzes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood samples are collected and a piece of biopsy will be used for the constitution of a specific collection in the CRB (Centre de ressource biologique)
Time Frame: At Day 1: day of surgery
Blood samples are collected and a piece of biopsy will be used for the constitution of a specific collection in the CRB (Centre de ressource biologique)
At Day 1: day of surgery

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Gabrielle Drevet, MD, Department of Thoracic Surgery - Louis Pradel Hospital

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 17, 2022

Primary Completion (Estimated)

November 17, 2024

Study Completion (Estimated)

November 17, 2024

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0116
  • 2021-A00761-40 (Other Identifier: ID-RCB)

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.

Clinical Trials on Pleural Effusion, Malignant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe