Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR)Mutation Status in Non-Small Cell Lung Cancer (NSCLC) in India.
Not Applicable
- Conditions
- Health Condition 1: null- Non Small Cell Lung Cancer
- Registration Number
- CTRI/2013/10/004077
- Lead Sponsor
- Roche Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
Inclusion Criteria
Patients must meet the following criteria for study entry:
· Adult male or female patients of age >= 18years.
· Diagnosed case of NSCLC with availability of representative tumor specimen for
genetic analysis, from the biopsy sample.
· Written informed consent
Exclusion Criteria
Patients who meet the following criteria will be excluded from study:
· Patients, who in the opinion of the investigator, are unable to comply with study
requirements
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of EGFR mutations in NSCLC patients in Indian population.Timepoint: Interim analysis will be done at completion of 50% of planned subjects are enrolled <br/ ><br>Expected at around March 2014
- Secondary Outcome Measures
Name Time Method â?¢Prevalence of different types of EGFR mutations in NSCLC patients in Indian population <br/ ><br>â?¢Correlation of EGFR mutation status with demography <br/ ><br>â?¢Correlation of EGFR mutation status with linico-pathological characteristics <br/ ><br>â?¢In treatment experienced patients, analysis of correlation between EGFR mutation and treatment outcomeTimepoint: Interim analysis will be done at completion of 50% of planned subjects are enrolled <br/ ><br>Expected at around Mar 2014 <br/ ><br>Final Analysis in Oct 2014