Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma

Pleural Mesothelioma Clinical Trial

— SCITH-MESO  

Official title:

Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823741
• Other study ID #: 69HCL20_0997
• Secondary ID: 2021-A00748-33
• Status: Recruiting
• Start date: February 11, 2022
• Est. completion date: February 11, 2026

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Jean-Michel MAURY, MD
• Phone: 04.72.35.75.90
• Email: jean-michel.maury[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 11, 2026
• Est. primary completion date: February 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Gene Abnormality
• Mesothelioma
• Mesothelioma, Malignant
• Pleural Mesothelioma

Intervention

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).

Locations

Country	Name	City	State
France	Département de chirurgie thoracique	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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)