Pleural Carcinomatosis Tissue Banking

NCT04844827 | Recruiting

• 2 other identifiers: 69HCL21_01162021-A00761-40
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion, Malignant

Keywords

Malignant pleural effusion; pleural carcinomatosis; pleural metastasis; tissue banking

Outcome Measures

Primary Outcomes (1)

• 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)

  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

Study Arms (1)

malignant pleural effusion

Patients with malignant pleural effusion who underwent pleural biopsies and blood tests under general anesthesia

Genetic: Conserving routinely performed pleural biopsies in our biological resources center to realize multiomics and bioinformatics analyzes secondarily

Interventions

Conserving routinely performed pleural biopsies in our biological resources center to realize multiomics and bioinformatics analyzes secondarily GENETIC

Interventions will consist of a diagnostic and symptomatic videothoracoscopy in patients with pleural metastasis under general anesthesia, as part of a standard of care procedure. Fragments of these pleural biopsies (one for routine diagnosis and two for scientific purposes) will enrich the biocollection. Five blood samples will be taken at the time of surgery (3 to 5 ml / tube). These biological samples will be stored in the HCL CRB tumor bank. At the same time, patient demographic data will be collected and anonymized. In the long term, the biological material will be used by IARC for carrying out multi-omics and bioinformatics analyzes

malignant pleural effusion

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study concerns adult patients with pleural metastasis eligible for a surgical exploration of the pleura

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Louis Pradel Hospital

Bron, 69500, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Between 3 and 5 pleural biopsies and 5 blood samples for each patient

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Gabrielle Drevet, MD

  Department of Thoracic Surgery - Louis Pradel Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabrielle Drevet, MD

CONTACT

04 72 35 75 54; gabrielle.drevet@chu-lyon.fr

Jean-Michel Maury, MD

CONTACT

04 72 35 75 90; jean-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: April 12, 2021
• First Posted: April 14, 2021
• Study Start: November 17, 2022
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

FR (1)