Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection

Completed

• Conditions: NON-SMALL-CELL LUNG CANCER

• Registration Number: NCT00831454
• Lead Sponsor: Armando Santoro, MD

Brief Summary

The aim of this study was to retrospectively evaluate associations between EGFR and AKT DNA-polymorphisms involved in transcriptional regulation and overall survival in NSCLC patients treated with EGFR-TKIs.

Detailed Description

DNA will be isolated from blood samples or paraffin-embedded tumor specimens and than a mutation analysis and SNPs genotyping will be done.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Availability of tumor tissue or blood samples.
• Diagnosis of NSCLC
• At least one treatment with EGFR-TKIs inhibitors

Exclusion Criteria

• Other than NSCLC primary diagnosis
• No treatment with EGFR-TKIs inhibitors
• No archival tissue available

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to evaluate the presence of EGFR- and AKT-DNA polymorphisms.	At the end of enrollment

Secondary Outcome Measures

Name	Time	Method
to correlate the biological characteristics with clinical characteristics and survival data of patients.	At the end of enrollment

Trial Locations

Locations (1)

Istituto Clinco Humanitas; 🇮🇹 Rozzano, Mialno, Italy