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Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956280
First Posted: August 11, 2009
Last Update Posted: May 13, 2010
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.
Collaborator:
Laboratorio Progenetica
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).

Condition
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC. [ Time Frame: March 31, 2010 ]

Estimated Enrollment: 100
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  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
Patients with Advanced Non Small Cell Lung Cancer
Criteria

Inclusion Criteria:

  • Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
  • Tumour sample (block of slides) available for KRAS analysis

Exclusion Criteria:

  • Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
  • Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)
  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): NCT00956280


Locations
Brazil
Research Site
Belo Horizonte, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
Santo André, Brazil
Research Site
São Paulo, Brazil
Sponsors and Collaborators
AstraZeneca
Laboratorio Progenetica
Investigators
Study Director: José Eduardo Pipolo das Neves, MD AstraZeneca do Brasil, MC Medical Director
  More Information

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00956280     History of Changes
Other Study ID Numbers: NIS-OBR-DUM-2008/1
IMPACT 14829
First Submitted: August 10, 2009
First Posted: August 11, 2009
Last Update Posted: May 13, 2010
Last Verified: May 2010

Keywords provided by AstraZeneca:
The frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC
KRAS mutation in population with advanced NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms