Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01167972
First received: July 20, 2010
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The main objective of the study is to determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma [ Time Frame: At baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe the therapeutic management according to the mutational status (EGFR M +, EGFR M- and Mx). [ Time Frame: 12 months / At each visit ] [ Designated as safety issue: No ]
  • Describe the therapeutic management of patients with EGFR M +. [ Time Frame: 12 months / At each visit ] [ Designated as safety issue: No ]
  • Describe the clinical course of patients EGFR-M +, treated for first-line treatment, and then 2nd line treatment, until 31-AUG-2012 [ Time Frame: 12 months / At each visit ] [ Designated as safety issue: No ]

Enrollment: 2000
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Detailed Description:

MSD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient with NSCLC adenocarcinoma confirmed by histologyPatient for whom a search for the mutational status of EGFR (EGFR-M +, M- or Mx) has been done or is being analyzed

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167972

  Show 101 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Corrine Bernaud, Medical Director AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01167972     History of Changes
Other Study ID Numbers: NIS-OFR-DUM-2010/1
Study First Received: July 20, 2010
Last Updated: September 7, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by AstraZeneca:
M + mutation
Non Small Cell Lung Cancer adenocarcinoma
To determine the proportion of patients with M + mutation status among patients with NSCLC adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Cystic, Mucinous, and Serous
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013