NCT00956280

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 13, 2010

Status Verified

May 1, 2010

Enrollment Period

7 months

First QC Date

August 10, 2009

Last Update Submit

May 11, 2010

Conditions

Non Small Cell Lung Cancer

Keywords

The frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLCKRAS mutation in population with advanced NSCLC

Outcome Measures

Primary Outcomes (1)

  • To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC.

    March 31, 2010

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Advanced Non Small Cell Lung Cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Belo Horizonte, Brazil

Location

Research Site

Porto Alegre, Brazil

Location

Research Site

Rio de Janeiro, Brazil

Location

Research Site

Santo André, Brazil

Location

Research Site

São Paulo, Brazil

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • José Eduardo Pipolo das Neves, MD

    AstraZeneca do Brasil, MC Medical Director

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 13, 2010

Record last verified: 2010-05

Locations

BR(5)