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

This study is ongoing, but not recruiting participants.

First Received: January 28, 2009 No Changes Posted

Sponsored by:	Istituto Clinico Humanitas
Information provided by:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00831454

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

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

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 ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Mitogens

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009