Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT01255150

Collaborator

(none)

Enrollment

Locations

52.9

Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Research has shown that the Epidermal Growth Factor Receptor (EGFR) gene is an important target for personalized lung cancer treatment. Individuals who have mutations in the EGFR gene have better responses when treated with certain personalized or targeted therapies compared with conventional chemotherapy. These mutations are more frequent in females with lung cancer who have never smoked, and different ethnic groups have different levels of frequency of the mutations. Researchers are interested in collecting more information on EGFR genetic mutations in Hispanics/Latinos with lung cancer, comparing the frequency of these mutations in males and females and smokers and nonsmokers. This study may lead to better, more personalized care approaches for all individuals with lung cancer.

Objectives:

To study the frequency of Epidermal Growth Factor Receptor mutations in Hispanic/Latino individuals who have been diagnosed with non-small cell lung cancer.

Eligibility:

Hispanic or Latino individuals who have been diagnosed with non-small cell lung cancer and who have lung tissue from a previous biopsy or surgery available for research purposes.

Design:

Participants will provide consent for researchers to examine lung tissue collected from a previous biopsy or surgery.
Treatment will not be provided as part of this protocol.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Carcinoma

Detailed Description

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.
Tissue samples from Hispanic or Latino individuals 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.

Study Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Ecologic or Community

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Dec 1, 2010

Study Completion Date :

Apr 29, 2015

Outcome Measures

Primary Outcome Measures

Frequency of EGFR mutations in Hispanic/Latinos with nonsmall cell lung cancer according to gender and smoking status [At tissue and data acquisition upon enrollment]
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 [At tissue and data acquisition upon enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Tumor samples from deceased Hispanic or Latino individuals with histologically confirmed non-small cell lung cancer for which basic clinical information is available

Pathological waste or surplus stored identified or coded non-small cell lung cancer specimens from Hispanic or Latino individuals for which there is linked clinical information but the location of the person is not feasible to determine.

EXCLUSION CRITERIA:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denver Health Medical Center	Denver	Colorado	United States	80204
2	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892
3	Kettering Health Network	Kettering	Ohio	United States	45429
4	Oregon Health and Sciences Universtiy Cancer Center	Portland	Oregon	United States	97239
5	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
6	Universidad Mayor de San Simon	Cochabamba		Bolivia
7	Universidad de Colima	Colima		Mexico	28040
8	Instituto Nacional de Cancerologia	Mexico City		Mexico	14080
9	Center for Research & Development in Health Sciences	Monterrey		Mexico	64460
10	Universidad Autonoma de Queretaro	Queretaro		Mexico
11	Instituto Nacional de Enfermedades Neoplasicas (INEN)	Lima		Peru
12	Instituto de Oncologia Luis Razetti	Caracas		Venezuela