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

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. Identifier: NCT00831454
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas

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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 51 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 identifier (NCT number): NCT00831454

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Istituto Clinco Humanitas
Rozzano, Mialno, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
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Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas Identifier: NCT00831454    
Other Study ID Numbers: ONC/OSS-02/2008
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms