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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04823741
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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).

Condition or disease Intervention/treatment
Mesothelioma, Malignant Gene Abnormality Pleural Mesothelioma Genetic: PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Mesothelioma

Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  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). [ 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).


Biospecimen Retention:   Samples With DNA
pleural samples of malignant pleural mesothelioma

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patient with suspected malignant pleural mesothelioma requiring surgical biopsy for diagnosis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823741


Contacts
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Contact: Jean-Michel MAURY, MD 04.72.35.75.90 ext +33 jean-michel.maury@chu-lyon.fr

Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04823741    
Other Study ID Numbers: 69HCL20_0997
2021-A00748-33 ( Other Identifier: ID-RCB )
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
malignant pleural mesothelioma
intra tumoral heterogeneity
genetic abnormalities
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Congenital Abnormalities
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
 Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases