Pleural Carcinomatosis Tissue Banking

Pleural Effusion, Malignant Clinical Trial

— TICP  

Official title:

Creation of a Pleural Carcinomatosis Tissue Bank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844827
• Other study ID #: 69HCL21_0116
• Secondary ID: 2021-A00761-40
• Status: Recruiting
• Start date: November 17, 2022
• Est. completion date: November 17, 2024

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Gabrielle Drevet, MD
• Phone: 04 72 35 75 54
• Email: gabrielle.drevet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 17, 2024
• Est. primary completion date: November 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Genetic:
• 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

Locations

Country	Name	City	State
France	Louis Pradel Hospital	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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