Viewing Study NCT01700582



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Last Modification Date: 2024-10-26 @ 10:57 AM
Study NCT ID: NCT01700582
Status: COMPLETED
Last Update Posted: 2023-07-21
First Post: 2012-08-01

Brief Title: French National Observatory of the Patients With Non-small Cell Lung NSCLC and Molecular Testings
Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Organization: Intergroupe Francophone de Cancerologie Thoracique

Study Overview

Official Title: French National Observatory of the Patients With Non-small Cell Lung NSCLC Benefiting From a Molecular Test on the Hospital Platforms of Molecular Genetics
Status: COMPLETED
Status Verified Date: 2023-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The French National Cancer Institute INCa support a 28 hospital platforms network for molecular testing of cancer patients These platforms routinely assess a panel of biomarkers in order to speed up access of French cancer patients to targeted therapies commercially available or through clinical trials

The objective of the BIOMARKERS-France study is to describe the epidemiological clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment ie bio-guided therapy as well as outcomes response rate progression free and overall survival
Detailed Description: The French National Cancer Institute INCa support a 28 hospital platforms network for molecular testing of cancer patients These platforms routinely assess a panel of biomarkers in order to speed up access of French cancer patients to targeted therapies commercially available or through clinical trials

Regarding stage IV non-squamous NSCLC patients 7 biomarkers are assessed including activating EGFR mutations EML4-ALK translocation and EGFR T790M KRAS BRAF HER2 and PI3KCA mutations In 2012 up to 17 to 20000 patients will be tested on this platform network

The objective of the BIOMARKERS-France study is to describe the epidemiological clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment ie bio-guided therapy as well as outcomes response rate progression free and overall survival

This study will collect in a prospective way data from a unique national cohort in order to guide future decisions regarding biomarker assessments type Number Methods Etc in connexion with all the other research works currently ongoing in France

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None