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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04823741
Other study ID # 69HCL20_0997
Secondary ID 2021-A00748-33
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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