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

NON-SMALL-CELL LUNG CANCER Clinical Trial

Official title:

Relationship of Polymorphisms and Mutations of Epidermal Growth Factor Receptor and Tyrosine Kinase Inhibitors Responsiveness in Non-small-cell Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831454
• Other study ID #: ONC/OSS-02/2008
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: November 27, 2014
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: November 2014
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NON-SMALL-CELL LUNG CANCER

Locations

Country	Name	City	State
Italy	Istituto Clinco Humanitas	Rozzano	Mialno

Sponsors (1)

Lead Sponsor	Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the presence of EGFR- and AKT-DNA polymorphisms.		At the end of enrollment	No
Secondary	to correlate the biological characteristics with clinical characteristics and survival data of patients.		At the end of enrollment	No