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

Non-Small Cell Lung Cancer Clinical Trial

— CB(NPC)²  

Official title:

Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448758
• Other study ID #: CB(NPC)²-1209
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2014
• Last updated: May 15, 2015
• Start date: September 2011
• Est. completion date: September 2017

Study information

• Verified date: May 2015
• Source: Centre Oscar Lambret
• Contact: Alexis CORTOT, MD, PhD
• Phone: +33 3 20 44 56 12
• Email: alexis.cortot[@]chru-lille.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 785
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	CHRU	Lille

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Centre de Biologie Pathologie : Plateforme de Biologie Moléculaire de Lille, University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between clinical factors and mutation status	The clinical factors are age, smoking status, occupational and environmental exposure, personal and family background, TNM stage, performance status	at baseline	No
Secondary	Progression-free survival		3 years	No
Secondary	Overall survival		3 years	No
Secondary	Number of patients included in a clinical trial dedicated to a certain type of non-small cell lung cancer with mutation		3 years	No
Secondary	Number of cases per mutation type		3 years	No