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

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

Tracking Information
First Submitted Date January 28, 2009
First Posted Date January 29, 2009
Last Update Posted Date December 2, 2014
Study Start Date September 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 28, 2009)
to evaluate the presence of EGFR- and AKT-DNA polymorphisms. [ Time Frame: At the end of enrollment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 28, 2009)
to correlate the biological characteristics with clinical characteristics and survival data of patients. [ Time Frame: At the end of enrollment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection
Official Title Relationship of Polymorphisms and Mutations of Epidermal Growth Factor Receptor and Tyrosine Kinase Inhibitors Responsiveness in Non-small-cell Lung Cancer Patients
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood samples tissue samples
Sampling Method Non-Probability Sample
Study Population NON-SMALL-CELL LUNG CANCER patients treated with EGFR-TKIs
Condition NON-SMALL-CELL LUNG CANCER
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 27, 2014)
51
Original Estimated Enrollment
 (submitted: January 28, 2009)
100
Actual Study Completion Date December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT00831454
Other Study ID Numbers ONC/OSS-02/2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Armando Santoro, MD, Istituto Clinico Humanitas
Study Sponsor Armando Santoro, MD
Collaborators Not Provided
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date November 2014