NCT04823741

Brief 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).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

March 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2026

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

March 26, 2021

Last Update Submit

January 30, 2024

Conditions

Mesothelioma, MalignantGene AbnormalityPleural Mesothelioma

Keywords

malignant pleural mesotheliomaintra tumoral heterogeneitygenetic abnormalities

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

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

Interventions

PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMAGENETIC

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).

PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de chirurgie thoracique

Bron, 69677, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

pleural samples of malignant pleural mesothelioma

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jean-Michel MAURY, MD

CONTACT

04.72.35.75.90jean-michel.maury@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 1, 2021

Study Start

February 11, 2022

Primary Completion

February 11, 2026

Study Completion

February 11, 2026

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

FR(1)