Pleural Carcinomatosis Tissue Banking

NCT ID: NCT04844827

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-17
• Study Completion Date: 2025-11-17

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

malignant pleural effusion

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

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

Intervention Type: 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

Interventions

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

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

Intervention Type: GENETIC

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabrielle Drevet, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Thoracic Surgery - Louis Pradel Hospital

Locations

Louis Pradel Hospital

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Gabrielle Drevet, MD

Role: CONTACT

gabrielle.drevet@chu-lyon.fr

04 72 35 75 54 ext. +33

Jean-Michel Maury, MD

Role: CONTACT

jean-michel.maury@chu-lyon.fr

04 72 35 75 90 ext. +33

Facility Contacts

Gabrielle Drevet, MD

Role: primary

gabrielle.drevet@chu-lyon.fr

4 72 35 75 54 ext. +33

Other Identifiers

2021-A00761-40

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL21_0116

Identifier Type: -

Identifier Source: org_study_id