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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00831454

Enrollment

Registered

2009-01-29

Start date

2008-09-30

Completion date

2011-12-31

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NON-SMALL-CELL LUNG CANCER

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results