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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00831454
First received: January 28, 2009
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  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 PATIENT

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Istituto Clinico Humanitas:

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 ]

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 ]

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: September 2008 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831454

Locations
Italy
Istituto Clinco Humanitas
Rozzano, Mialno, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00831454     History of Changes
Other Study ID Numbers: ONC/OSS-02/2008
Study First Received: January 28, 2009
Last Updated: September 1, 2010
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on October 18, 2012