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

November 20, 2019 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Bolivia
- - Cochabamba, Bolivia
    - Universidad Mayor de San Simon
Mexico
- - Colima, Mexico, 28040
    - Universidad de Colima
  - Mexico City, Mexico, 14080
    - Instituto Nacional de Cancerologia
  - Monterrey, Mexico, 64460
    - Center for Research & Development in Health Sciences
  - Queretaro, Mexico
    - Universidad Autonoma de Queretaro
Peru
- - Lima, Peru
    - Instituto Nacional de Enfermedades Neoplásicas (INEN)
United States
- Colorado
  - Denver, Colorado, United States, 80204
    - Denver Health Medical Center
- Maryland
  - Bethesda, Maryland, United States, 20892
    - National Institutes of Health Clinical Center, 9000 Rockville Pike
- Ohio
  - Kettering, Ohio, United States, 45429
    - Kettering Health Network
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health and Sciences Universtiy Cancer Center
- Texas
  - Dallas, Texas, United States, 75390
    - University of Texas Southwestern Medical Center
Venezuela
- - Caracas, Venezuela
    - Instituto de Oncologia Luis Razetti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of EGFR mutations in Hispanic/Latinos with nonsmall cell lung cancer according to gender and smoking status Time Frame: At tissue and data acquisition upon enrollment	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 Time Frame: At tissue and data acquisition upon enrollment	At tissue and data acquisition upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Study Completion

April 29, 2015

Study Registration Dates

First Submitted

December 4, 2010

First Submitted That Met QC Criteria