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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01255150
First received: December 4, 2010
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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
Non-Small-Cell Lung Carcinoma

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Frequency of Epidermal Growth Factor Receptor Mutations in Latinos/Hispanics With Non-Small Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: December 2010
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.
  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255150

Locations
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Ohio
Kettering Health Network
Kettering, Ohio, United States, 45429
United States, Oregon
Oregon Health and Sciences Universtiy Cancer Center
Portland, Oregon, United States, 97239
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Bolivia
Universidad Mayor de San Simon
Cochabamba, Bolivia
Mexico
Universidad de Colima
Colima, Mexico, 28040
Instituto Nacional de Cancerologia
Mexico City, Mexico, 14080
Center for Research & Development in Health Sciences
Monterrey, Mexico, 64460
Universidad Autonoma de Queretaro
Queretaro, Mexico
Peru
Instituto Nacional de Enfermedades Neoplasicas (INEN)
Lima, Peru
Venezuela
Instituto de Oncologia Luis Razetti
Caracas, Venezuela
Sponsors and Collaborators
Investigators
Principal Investigator: Arun Rajan, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01255150     History of Changes
Other Study ID Numbers: 110044, 11-C-0044
Study First Received: December 4, 2010
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Genetic Ancestry Analysis
Molecular Profiling
Smoking Status
Wood Smoke Exposure
EGFR Mutation Analysis
Non Small Cell Lung Cancer

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

ClinicalTrials.gov processed this record on July 23, 2014