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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 May 29, 2015
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms