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Recruiting NCT04300062

Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rebiopsy.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Incidence of specific histomolecular resistance [Time frame: At the end of study, up to 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Service de Pneumologie et Oncologie thoracique, Hôpital Ambroise Paré, APHP — Boulogne-Billancourt

Publications

  • Giroux Leprieur E, Dumenil C, Julie C, Giraud V, Dumoulin J, Labrune S, Chinet T. Immunotherapy revolutionises non-small-cell lung cancer therapy: Results, perspectives and new challenges. Eur J Cancer. 2017 Jun;78:16-23. doi: 10.1016/j.ejca.2016.12.041. Epub 2017 Apr 11. PMID 28407528

Identifiers

NCT: NCT04300062 · APHP200398

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗