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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167972
First Posted: July 22, 2010
Last Update Posted: September 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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:


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 ]

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 ]
  • Describe the therapeutic management of patients with EGFR M +. [ Time Frame: 12 months / At each visit ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167972


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01167972     History of Changes
Other Study ID Numbers: NIS-OFR-DUM-2010/1
First Submitted: July 20, 2010
First Posted: July 22, 2010
Last Update Posted: September 10, 2012
Last Verified: September 2012

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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type