Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Renal Cell

Pleural Effusion, Malignant

Pleural Effusion

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Pleural Diseases

Pleural Neoplasms

Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

40 mg of the nivolumab will be used intrapleurally (once).

Ilya Tsimafeyeu, M.D.

Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.

Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)

Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.

A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.

Proportion of patients who will be without signs of radiographic recurrence after 3 months

Percentage of patients who will experience any grade adverse events (according to CTCAE criteria ver. 5.0) associated with intrapleural nivolumab use

Kidney Cancer Research Bureau

Mesothelioma

Mesothelioma, Malignant

Malignant Mesothelioma

Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies

Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.

Study of the pleural cavity with a confocal laser endomicroscope.

Olivier Bonhomme, MD

Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level ("optical biopsies"). It was first used in gastroenterology and came later to the light in pulmonary medicine and is still an experimental technique. In gastroenterology, this new investigational technique is used in Barret oesophagus, inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be studied only during live imaging as microorganisms or bloodflows. The investigators performed an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who agreed to participate. The pCLE features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.

Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.

Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table

Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.

Here are presented Mean cell size and maximum vascular diameter

Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.

Quantitative criteria are presented in this table. Here is presented the mean cellular density

Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.

Quantitative criteria are presented in this table. Here is presented the vascular density.

The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.

University of Liege

Medical doctor - clinical assistant

Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies

Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.

Patient Aged More Than 18 Years Admitted for Thoracoscopy

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Thoracoscopy indication

Final histological diagnosis

Dr Olivier Bonhomme

The objective of the test is to assess if the pCLE feature "full chia seed sign" is found statistically more frequently in the "benign pleura group" than in the "malignant pleural infiltrations group".

The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the "malignant pleural infiltrations group" than in the "benign pleura group".

The objective is to assess if the pCLE feature "cellular shape homogeneity" is found statistically more frequently in the "benign pleura group" than in the "malignant pleural infiltrations group".

The objective is to assess if dysplastic vessels are more frequently found in the "malignant pleural infiltrations group" than in the "benign pleura group".

Abnormal tissular architecture

Cellular size homogeneity

Cellular shape homogeneity

Cellular fluorescence homogeneity

Blood vessels dysplasia

Organized connective tissue

Chia seed sign

Participants with a benign pleura histological diagnosis.

Benign Pleura

Participants with a malignant pleural disease demonstrated by biopsies.

Malignant Pleural Infiltrations

Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.

Mean cell size

Maximal vascular diameter

Some criteria were not assessable for some patients.

Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.

Quality of the pCLE Acquisition

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Central Nervous System Depressants

Anesthetics

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

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

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

Gabrielle Drevet, MD

Jean-Michel Maury, MD

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.

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

Pleural Carcinomatosis Tissue Banking

Creation of a Pleural Carcinomatosis Tissue Bank

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.	NCT04749602	Renal Cell Canc... Non-small Cell ... Pleural Effusio...	Nivolumab	18 Years -	Kidney Cancer Research Bureau
Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.	NCT03805971	Pleural Carcino...	Study of the pl...	18 Years -	University of Liege
Pleural Carcinomatosis Tissue Banking	NCT04844827	Pleural Effusio...	Conserving rout...	18 Years - 110 Years	Hospices Civils de Lyon
Pleural Carcinomatosis Tissue Banking	NCT04844827	Pleural Effusio...	Conserving rout...	18 Years - 110 Years	Hospices Civils de Lyon

Spots Global Cancer Trial Database for pleural carcinomatosis