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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:
Collaborator:
Laboratorio Progenetica
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00956280
First received: August 10, 2009
Last updated: May 11, 2010
Last verified: May 2010
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00956280     History of Changes
Other Study ID Numbers: NIS-OBR-DUM-2008/1, IMPACT 14829
Study First Received: August 10, 2009
Last Updated: May 11, 2010
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on November 25, 2014