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Report for Clinical Trial NCT02086071

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Feasibility of New Biological and Histological Samples at Progression for Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)

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.

NCT02086071 Lung Cancer
MeSH:Lung Neoplasms
HPO:Neoplasm of the lung

1 Interventions

Name: re biopsy

Description: re biopsy depending on the location of the pathology
Type: Procedure
Group Labels: 1

Re biopsies feasibility


Primary Outcomes

Description: 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.

Measure: Feasibility of re-biopsies

Time: 18 months / 100 patients

Secondary Outcomes

Description: Comparison of types and numbers of resistances before treatment (on the first biopsy) and after treatment (on the re-biopsy). Appearance and/or disappearance of some resistances.

Measure: Type of resistance

Time: 18 months/100 patients

Description: Description of population: age, performance status, smoking status, sex (number, medium, maximum, minimum). Description of treatment: chemotherapy (type and products), radiotherapy (site), surgery (site)

Measure: Disease management

Time: 18 months / 100 patients

Description: Description and comparison of histology on the first biopsy and on the rebiopsy

Measure: Biological history of the disease

Time: 18 months / 100 patients

Purpose: Basic Science

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 T790M

One of the major resistance mechanisms is the onset of T790M mutation, which induces a non sensitivity to TKIs. --- T790M ---

has depicted the resistance mechanisms as mutation T790M or oncogene cMet (CMet) amplification. --- T790M ---


2 T890M

has depicted the resistance mechanisms as Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. --- T890M ---



HPO Nodes


HPO: