Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma (SCITH-MESO)

January 30, 2024 updated by: Hospices Civils de Lyon
Malignant pleural mesothelioma (MPM) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. To enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. One of the principal difficulty is to harvest sufficient tumour pieces to perform multi-omics analysis. The goal of the SCITH-MESO study is to harvest larges pieces of tumour during a routine surgical procedure of MPM diagnosis by mean of pleural biopsies during VATS surgery. Operating samples will increase a tissue bank collection (CRB).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

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 to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all patient with suspected malignant pleural mesothelioma requiring surgical biopsy for diagnosis

Description

Inclusion Criteria:

  • age >18
  • suspected MPM requiring VATS biopsy after multidisciplinary oncologic board validation
  • patient able to understand study objectives and able to give an informed consent
  • patient affiliated to an healthcare society.

Exclusion Criteria:

  • pregnancy
  • mental disease, psychiatric disorder
  • patient under protection regimen

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA
All patient with suspected malignant pleural mesothelioma requiring surgical biopsy after validation in oncologic multidisciplinary board will be included. During a standardized routine procedure of pleural biopsy by mean of general anesthesia and video thoracoscopic approach, 3 - 5 biopsies are realized. During this procedure, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
Genetic: PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA
All patient with suspected malignant pleural mesothelioma requiring surgical biopsy after validation in oncologic multidisciplinary board will be included. During a standardized routine procedure of pleural biopsy by mean of general anesthesia and video thoracoscopic approach, 3 - 5 biopsies are realized. During this procedure, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For patients with MPM, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
Time Frame: day 1 (day of chirurgie)
For patients with MPM, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
day 1 (day of chirurgie)

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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)

February 11, 2022

Primary Completion (Estimated)

February 11, 2026

Study Completion (Estimated)

February 11, 2026

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_0997
  • 2021-A00748-33 (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.

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