TICP: Pleural Carcinomatosis Tissue Banking

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04844827
Collaborator
(none)
100
1
36
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Conserving routinely performed pleural biopsies in our biological resources center to realize multiomics and bioinformatics analyzes secondarily

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Creation of a Pleural Carcinomatosis Tissue Bank
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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 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

Outcome Measures

Primary Outcome Measures

  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) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Louis Pradel Hospital Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Gabrielle Drevet, MD, Department of Thoracic Surgery - Louis Pradel Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04844827
Other Study ID Numbers:
  • 69HCL21_0116
  • 2021-A00761-40
First Posted:
Apr 14, 2021
Last Update Posted:
Apr 14, 2021
Last Verified:
Apr 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2021