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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00831454
First received: January 28, 2009
Last updated: November 27, 2014
Last verified: November 2014
  Purpose

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.


Condition
NON-SMALL-CELL LUNG CANCER

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship of Polymorphisms and Mutations of Epidermal Growth Factor Receptor and Tyrosine Kinase Inhibitors Responsiveness in Non-small-cell Lung Cancer Patients

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • to evaluate the presence of EGFR- and AKT-DNA polymorphisms. [ Time Frame: At the end of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to correlate the biological characteristics with clinical characteristics and survival data of patients. [ Time Frame: At the end of enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples tissue samples


Enrollment: 51
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

NON-SMALL-CELL LUNG CANCER patients treated with EGFR-TKIs

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00831454

Locations
Italy
Istituto Clinco Humanitas
Rozzano, Mialno, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00831454     History of Changes
Other Study ID Numbers: ONC/OSS-02/2008
Study First Received: January 28, 2009
Last Updated: November 27, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on April 19, 2015