Pleural Carcinomatosis Tissue Banking

Recruiting

• Conditions: Pleural Effusion, Malignant
• Interventions: Genetic: Conserving routinely performed pleural biopsies in our biological resources center to realize multiomics and bioinformatics analyzes secondarily

• Registration Number: NCT04844827
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Malignant pleural effusion is a common evolution of various cancers and is associated with poor prognosis and quality of life. About 28% of patients with primary malignancy will develop pleural metastasis. Malignant pleural effusion mostly occurs in lung, breast, ovarian and gastric cancers. Median survival ranges from 3 to 13 months according to primary malignancy. Currently, the therapeutic approach is mainly palliative with videothoracoscopic talc pleurodesis or indwelling pleural catheters insertion eventually associated with systemic chemotherapy if patient's general condition allows.

In a early-disseminated tumor cells profile, metastatic cells can accumulate alterations at a distant site and have a different profil from the original tumor cells. Metastatic cells can also accumulate alterations in the course if systemic treatments. Consequently, they may respond differently to drugs.

Recently, EGFR mutations and ALK status discordance between primary tumors and pleural metastases have been demonstrated in a significant portion of lung adenocarcinomas. These studies, realized on malignant pleural effusion isolated cells, enabled us to hypothesize a possible intratumoral heterogeneity within pleural metastases, but no study has been carried out on pleural tissue.

Our aim is to create a biocollection with tissues from pleural carcinomatosis in order to subsequently allow multiomics and bioinformatics analyzes and to characterize a possible intratumoral heterogeneity in pleural metastasis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Study Start: 2022-11-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-11-17
• Study Completion: 2025-11-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male or female over 18 years old
• Malignant pleural effusion with or without prior histological or cytological diagnosis
• Patient eligible for a pleural biopsy for diagnostic purposes and validated in a multidisciplinary consultation meeting
• Having given their free and informed writing consent
• Affiliated to a social security system or assimilated

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Exclusion Criteria

• Malignant pleural mesothelioma
• Contraindication to general anesthesia
• Pregnant or breastfeeding woman, or is of child bearing potential and who did not agree to use highly effective methods of birth control throughout the study.
• Patient participating in a interventional study likely to interfere with this study
• Patient benefiting from a legal protection measure (guardianship or curatorship)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
malignant pleural effusion	Conserving routinely performed pleural biopsies in our biological resources center to realize multiomics and bioinformatics analyzes secondarily	Patients with malignant pleural effusion who underwent pleural biopsies and blood tests under general anesthesia

Primary Outcome Measures

Name	Time	Method
Blood samples are collected and a piece of biopsy will be used for the constitution of a specific collection in the CRB (Centre de ressource biologique)	At Day 1: day of surgery	Blood samples are collected and a piece of biopsy will be used for the constitution of a specific collection in the CRB (Centre de ressource biologique)

Trial Locations

Locations (1)

Louis Pradel Hospital; 🇫🇷 Bron, France