Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais (CB(NPC)²)

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT02448758
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

The investigators propose to create a database at the regional level, the principle is to include all patients in whom a mutation was detected from a single platform (Lille). The creation of this regional cohort, smaller than the national cohort of Biomarkers France, will perform a more comprehensive collection of clinical data, and molecular monitoring data of patients included. To increase the completeness of the collection of information, it will not be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated to this activity.

Detailed Description

This is a prospective and retrospective study of a population of patients with mutated non-small cell lung cancer in the Nord Pas de Calais. Retrospective cohort will involve patients with main molecular abnormalities, identifiable from molecular biology platform CRRC, except EGFR and KRAS treated from September 2011 to February 2013.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-03-06
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-15
• Last Update Submitted: 2015-05-15
• Study First Posted: 2015-05-19
• Last Update Posted: 2015-05-19
• Primary Completion: 2016-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 785

Inclusion Criteria

• Aged ≥ 18 years old
• Patient with non-small cell lung cancer
• Detected in the Nord Pas de Calais
• Monitored in the Nord Pas de Calais
• Patient must have signed a non-opposition form to the use of medical data

Exclusion Criteria

• No identified mutation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between clinical factors and mutation status	at baseline	The clinical factors are age, smoking status, occupational and environmental exposure, personal and family background, TNM stage, performance status

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	3 years
Overall survival	3 years
Number of patients included in a clinical trial dedicated to a certain type of non-small cell lung cancer with mutation	3 years
Number of cases per mutation type	3 years

Trial Locations

Locations (2)

Centre Oscar Lambret; 🇫🇷 Lille, France

CHRU; 🇫🇷 Lille, France