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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00831454
First Posted: January 29, 2009
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
  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

Resource links provided by NLM:


Further study details as provided by Armando Santoro, MD, Istituto Clinico Humanitas:

Primary Outcome Measures:
  • to evaluate the presence of EGFR- and AKT-DNA polymorphisms. [ Time Frame: At the end of enrollment ]

Secondary Outcome Measures:
  • to correlate the biological characteristics with clinical characteristics and survival data of patients. [ Time Frame: At the end of enrollment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00831454     History of Changes
Other Study ID Numbers: ONC/OSS-02/2008
First Submitted: January 28, 2009
First Posted: January 29, 2009
Last Update Posted: December 2, 2014
Last Verified: November 2014

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