Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection
This study has been completed.
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
First received: January 28, 2009
Last updated: November 27, 2014
Last verified: November 2014
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.
NON-SMALL-CELL LUNG CANCER
||Observational Model: Cohort
Time Perspective: Retrospective
||Relationship of Polymorphisms and Mutations of Epidermal Growth Factor Receptor and Tyrosine Kinase Inhibitors Responsiveness in Non-small-cell Lung Cancer Patients
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 ]
Biospecimen Retention: Samples With DNA
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 ]
blood samples tissue samples
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
DNA will be isolated from blood samples or paraffin-embedded tumor specimens and than a mutation analysis and SNPs genotyping will be done.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
NON-SMALL-CELL LUNG CANCER patients treated with EGFR-TKIs
- Availability of tumor tissue or blood samples.
- Diagnosis of NSCLC
- At least one treatment with EGFR-TKIs inhibitors
- Other than NSCLC primary diagnosis
- No treatment with EGFR-TKIs inhibitors
- No archival tissue available
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00831454
|Istituto Clinco Humanitas
|Rozzano, Mialno, Italy, 20089 |
Armando Santoro, MD
||Armando Santoro, MD
||Istituto Clinico Humanitas
No publications provided
||Armando Santoro, MD, MD, Istituto Clinico Humanitas
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 28, 2009
||November 27, 2014
||Italy: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 05, 2015
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms