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Frequency of Epidermal Growth Factor Receptor Mutations in Latinos/Hispanics With Non-Small Lung Cancer


N/A
2 Years
N/A
Open (Enrolling)
Both
Non-Small-Cell Lung Carcinoma

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Trial Information

Frequency of Epidermal Growth Factor Receptor Mutations in Latinos/Hispanics With Non-Small Lung Cancer


Background:

There is a growing body of evidence that points to genetic heterogeneity of the EGFR pathway
in non-small cell lung cancer among different ethnic groups and that underscores the need
for consideration of these differences in patient management and in the design of future
trials of agents that target the EGFR pathway. Activating mutations in EGFR have been found
in about 15% of NSCLC patients from North America and Europe, 40% of Asian and 2% in
African-Americans. However, there is no data on the frequency of EGFR mutations in U.S.
Hispanic and Latin American patients with NSCLC.

Primary Protocol Objectives:

- To determine the frequency of EGFR mutations in Hispanic/Latinos with non-small cell
lung cancer according to gender and smoking status.

- To study the association between the frequency of EGFR mutations and the percentage of
American Indian ancestry, as defined by genetic ancestry analysis, in Hispanic/Latinos
with non-small cell lung cancer.

Secondary Protocol Objectives:

-To evaluate the association between EGFR mutations and other clinical variables such as
wood smoke exposure, age, stage at presentation, nationality and response to EGFR TKIs.

Eligibility:

Hispanic or Latino patients with histologically confirmed non-small cell lung cancer.

Design:

Paraffin embedded tumor samples from Latino patients with non-small cell lung cancer will be
collected at the NIH's clinical center and the participating institutions.

Samples and clinical data will then be sent to the molecular pathology laboratory for EGFR
mutation analyses. The remainder DNA will then used for genetic ancestry analysis.

Inclusion Criteria


- INCLUSION CRITERIA:

Hispanic or Latino* patients with histologically confirmed non-small cell lung cancer.

* For the purpose of this study, the terms Hispanic or Latino is defined as an individual
who either self identifies as Hispanic or Latino or was born in any Latin American
country.

EXCLUSION CRITERIA:

Patients born in Europe, Asia, Africa or Australia are excluded.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Arun Rajan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

110044

NCT ID:

NCT01255150

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Genetic Ancestry Analysis
  • Molecular Profiling
  • Smoking Status
  • Wood Smoke Exposure
  • EGFR Mutation Analysis
  • Non Small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892
Denver Health Medical CenterDenver, Colorado  80204-4507
University of Texas Southwestern Medical CenterDallas, Texas  
Kettering Health NetworkKettering, Ohio  45429
Oregon Health and Sciences Universtiy Cancer CenterPortland, Oregon  97239