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REBIMMUNE: Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04300062
Collaborator
(none)
150
Enrollment
1
Location
1
Arm
23.4
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study aims to collect tumor tissue at the moment of progression under Immune checkpoint inhibitors (ICI) in biological resources center in Ambroise Paré hospital, in order to insure later study on molecular mechanism involving the progression of NSCLC and SCLC under ICI.

The further analysis of research will be performed in the EA 4340 unity, Biomarkers and Clinical Trials in cancerology and onco-hematology, UVSQ, University of Paris-Saclay.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Rebiopsy
 N/A

Detailed Description

The study will consist of creation a tumor tissue bank, all sampling will be stored in the biological resources center of Ambroise Paré hospital.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer
Actual Study Start Date :
Aug 18, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rebiopsy

Procedure: Rebiopsy
Biopsy will be carry out with flexible bronchoscopy as usual practice under local anesthesia: under endobronchial ultrasound, punction under CT scan or ultrasonography, percutaneous pleural puncturing.

Outcome Measures

Primary Outcome Measures

  1. Incidence of specific histomolecular resistance [At the end of study, up to 2 years]

    Banking of tumor samples at progression with immune checkpoint inhibitor (ICI) in lung cancer, to evaluate the incidence of specific histomolecular resistance mechanisms to ICI by immunohistochemistry and molecular testing.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosed NSCLC or SCLC;

  • Patient treated priorly by ICI and progressed under ICI;

  • Have provided written informed consent for the study;

  • Be >/= 18 years of age on day of signing informed consent.

Exclusion Criteria:

  • Patient under guardianship or curatorship;

  • Unable to provide written informed consent for the study;

  • Technical impossibility to carry out tissular rebiopsy under local anesthesia.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP Boulogne-Billancourt France 92100

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Etienne Giroux Leprieur, MD, PhD, Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04300062
Other Study ID Numbers:
  • 2020-A00035-34
First Posted:
Mar 9, 2020
Last Update Posted:
Dec 16, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
lung cancer
rebiopsy
immunotherapy
progression
Additional relevant MeSH terms:
Lung Neoplasms
Disease Progression

Study Results

No Results Posted as of Dec 16, 2020