Feasibility of re Biopsies at Progression

NCT02086071 | Completed DMC

• 1 other identifier: GFPC-REBIOP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

Brief Summary

Feasibility of new biological and histological samples at progression in patients with advanced or metastatic Non Small Cell Lung Cancer (NSCLC). A recent paper from Professor Sequist and coll. has depicted the resistance mechanisms as Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3 patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of the disease. This study will be conducted by the French Group of Pneumology-Oncology (Groupe Français de Pneumo Cancérologie (GFPC)) up to 100 patients during 18 Months. Each center will have to define if re-biopsies are possible or not and explain why not.

Conditions

Lung Cancer

Keywords

REBIOP re-biopsies advanced or metastatic NSCLC

Outcome Measures

Primary Outcomes (1)

• Feasibility of re-biopsies

  Feasibility of re-biopsies in patients with advanced or metastatic NSCLC after progression of disease under treatment. If the re-biopsy could not be performed : reason of no re-biopsy. If the biopsy could be performed : site and method of rebiopsy.

  18 months / 100 patients

Secondary Outcomes (3)

• Type of resistance

  18 months/100 patients

• Disease management

  18 months / 100 patients

• Biological history of the disease

  18 months / 100 patients

Study Arms (1)

Re biopsies feasibility

OTHER

the Interest of the study is to evaluate the feasibility of the re biopsy; the re biopsy is done if the patient agrees to perform it.

Procedure: re biopsy

Interventions

re biopsy PROCEDURE

re biopsy depending on the location of the pathology

Re biopsies feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All the patient more than 18 years old with advanced or metastatic NSCLC in progression after one or more treatment by chemotherapy.

You may not qualify if:

• SCLC, neuroendocrine carcinoma,
• Patients with judicial protection or deprived of liberty

Sponsors & Collaborators

• Groupe Francais De Pneumo-Cancerologie: lead

Study Sites (9)

Centre Hospitalier Universitaire

Angers, 49033, France

Location

Centre Hospitalier du Morvan

Brest, 29200, France

Location

Centre François Baclesse

Caen, 14000, France

Location

Site 04

Gap, 05000, France

Location

Hospital du Cluzeau

Limoges, 87042, France

Location

Site 25

Mantes-la-Jolie, 78200, France

Location

Site 06

Marseille, 13274, France

Location

Hospital Saint Antoine

Paris, 75012, France

Location

Site 20

Rennes, 35033, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• DUJON Cécile, MD

  CENTRE HOSPITALIER André MIGNOT VERSAILLES FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2013
• First Posted: March 13, 2014
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: March 13, 2020

Record last verified: 2014-03

Locations

FR (9)