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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 10, 2009

Last Updated Date

May 11, 2010

Start Date ^ICMJE

September 2009

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC. [ Time Frame: January 31, 2010 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00956280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with Advanced Non Small Cell Lung Cancer

Condition ^ICMJE

Non Small Cell Lung Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

100

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00956280

Other Study ID Numbers ^ICMJE

NIS-OBR-DUM-2008/1, IMPACT 14829

Has Data Monitoring Committee

Responsible Party

MC MD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Laboratorio Progenetica

Investigators ^ICMJE

Study Director:

José Eduardo Pipolo das Neves, MD

AstraZeneca do Brasil, MC Medical Director

Information Provided By

AstraZeneca

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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