Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04844827
Other study ID # 69HCL21_0116
Secondary ID 2021-A00761-40
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05693727 - Cancer Ratio,Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}for Differentiation Between Malignant and Non Malignant Pleural Effusion
Recruiting NCT05910112 - Prospective Data Collection on Clinical, Radiological and Patient Reported Outcomes After Pleural Intervention
Completed NCT03272997 - The Value of PET-CT in Pleural Effusions
Completed NCT03270215 - The Added Value of CT Scanning in Patients With an Unilateral Pleural Effusion
Completed NCT00099541 - Non-small Cell Lung Cancer Registry Phase 4
Recruiting NCT05278975 - Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma Phase 1/Phase 2
Recruiting NCT02407912 - Cisplatin for Malignant Pleural Effusion in Patients With Non-small-cell Lung Cancer N/A
Terminated NCT00316134 - Multiple Biomarkers in Undiagnosed Pleural Effusion N/A
Not yet recruiting NCT06275178 - Medical Thoracoscopy for Diagnosing Unexplained Pleural Effusion: a National Multicenter Retrospective Study
Recruiting NCT04684459 - Dual-targeting HER2 and PD-L1 CAR-T for Cancers With Pleural or Peritoneal Metastasis Early Phase 1
Recruiting NCT04670562 - Longitudinal Follow up of Patients With Pleural Effusion
Not yet recruiting NCT02805062 - Manometry vs Clinical Assessment in the Detection of Trapped Lung in Patients With Suspected Pleural Malignancy N/A
Completed NCT03276715 - Prognostic Factors on Malignant Pleural Effusion
Completed NCT03394105 - Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer Phase 2
Recruiting NCT05461430 - Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)
Terminated NCT02702700 - Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies Phase 1
Recruiting NCT02045121 - Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management N/A
Completed NCT01670786 - Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion Phase 4
Active, not recruiting NCT05077111 - A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia Phase 4
Not yet recruiting NCT03781908 - Management of Malignant Pleural Effusion With Indwelling Pleural Catheter Versus Silver Nitrate Pleurodesis Phase 1/Phase 2