Observational Study on the Management of Patients With Non Small Cell Lung Cancer Adenocarcinoma

Non Small Cell Lung Cancer Clinical Trial

— MUTACT  

Official title:

Observational Study on the Management of Patients With Non Small Cell Lung Cancer (NSCLC) Adenocarcinoma Tested for the Activating Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase (EGFR TK)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167972
• Other study ID #: NIS-OFR-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: September 7, 2012
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

The main objective of the study is to determine the proportion of patients with M + mutation status among patients with Non Small Cell Lung Cancer adenocarcinoma.

Description:

MSD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with lung cancer (Non Small Cell Lung Cancer adenocarcinoma)

• Patient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed

Exclusion Criteria:

• Assessment of mutational status of EGFR is not done

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Research Site	Abbeville
France	Research Site	Aix En Provence
France	Research Site	Amilly
France	Research Site	Angers
France	Research Site	Antibes
France	Research Site	Arras
France	Research Site	Aulnay Sous Bois
France	Research Site	Auxerre
France	Research Site	Bastia
France	Research Site	Bayonne
France	Research Site	Bethune
France	Research Site	Blois
France	Research Site	Bobigny
France	Research Site	Bois Guillaume
France	Research Site	Bonneville
France	Research Site	Bordeaux
France	Research Site	Boulogne Sur Mer
France	Research Site	Bourg En Bresse
France	Research Site	Brest
France	Research Site	Brive La Gaillarde
France	Research Site	Bron
France	Research Site	Caen
France	Research Site	Chalon Sur Saone
France	Research Site	Chauny
France	Research Site	Clermont Ferrand
France	Research Site	Colmar
France	Research Site	Compiegne
France	Research Site	Creil
France	Research Site	Creteil
France	Research Site	Dijon
France	Research Site	Douai
France	Research Site	Draguignan
France	Research Site	Fougeres
France	Research Site	GAP
France	Research Site	Granville
France	Research Site	La Roche Sur Yon
France	Research Site	La Rochelle
France	Research Site	La Seyne Sur Mer
France	Research Site	La Source
France	Research Site	La Tronche
France	Research Site	Le Plessis Robinson
France	Research Site	Lens
France	Research Site	Levallois Perret
France	Research Site	Libourne
France	Research Site	Lievin
France	Research Site	Lille
France	Research Site	Limoges
France	Research Site	Longjumeau
France	Research Site	Lyon
France	Research Site	Mantes La Jolie
France	Research Site	Marseille
France	Research Site	Meaux
France	Research Site	Mont de Marsan
France	Research Site	Mont St Martin
France	Research Site	Montauban
France	Research Site	Montivilliers
France	Research Site	Montpellier
France	Research Site	Moulins
France	Research Site	Nevers
France	Research Site	Nimes
France	Research Site	Niort
France	Research Site	Oloron Ste Marie
France	Research Site	Paris
France	Research Site	PAU
France	Research Site	Pessac
France	Research Site	Pierre Benite
France	Research Site	Poitiers
France	Research Site	Pontivy
France	Research Site	Pontoise
France	Research Site	Pringy
France	Research Site	Privas
France	Research Site	Redon
France	Research Site	Reims
France	Research Site	Rennes
France	Research Site	Roanne
France	Research Site	Rouen
France	Research Site	Saintes
France	Research Site	Salouel
France	Research Site	Sarrebourg
France	Research Site	Soissons
France	Research Site	St Aubin Les Elbeuf
France	Research Site	St Brieuc
France	Research Site	St Denis
France	Research Site	St Herblain
France	Research Site	St Pierre
France	Research Site	St Priest En Jarez
France	Research Site	St Quentin
France	Research Site	Ste Clotilde
France	Research Site	Ste Feyre
France	Research Site	Strasbourg
France	Research Site	Toulon
France	Research Site	Toulouse
France	Research Site	Tourcoing
France	Research Site	Tours
France	Research Site	Trappes
France	Research Site	Valence
France	Research Site	Vendome
France	Research Site	Verdun
France	Research Site	Villejuif
France	Research Site	Villenave D Ornon
France	Research Site	Yerres

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main objective of the study is to determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma		At baseline	No
Secondary	Describe the therapeutic management according to the mutational status (EGFR M +, EGFR M- and Mx).		12 months / At each visit	No
Secondary	Describe the therapeutic management of patients with EGFR M +.		12 months / At each visit	No
Secondary	Describe the clinical course of patients EGFR-M +, treated for first-line treatment, and then 2nd line treatment, until 31-AUG-2012		12 months / At each visit	No