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

Non-Small-Cell Lung Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255150
• Other study ID #: 110044
• Secondary ID: 11-C-0044
• Status: Completed
• Start date: December 1, 2010
• Est. completion date: April 29, 2015

Study information

• Verified date: April 29, 2015
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Venezuela,  Bolivia,  Mexico,  Peru, 

References & Publications (3)

Clegg LX, Li FP, Hankey BF, Chu K, Edwards BK. Cancer survival among US whites and minorities: a SEER (Surveillance, Epidemiology, and End Results) Program population-based study. Arch Intern Med. 2002 Sep 23;162(17):1985-93. — View Citation

Farjah F, Wood DE, Yanez ND 3rd, Vaughan TL, Symons RG, Krishnadasan B, Flum DR. Racial disparities among patients with lung cancer who were recommended operative therapy. Arch Surg. 2009 Jan;144(1):14-8. doi: 10.1001/archsurg.2008.519. — View Citation

Wisnivesky JP, McGinn T, Henschke C, Hebert P, Iannuzzi MC, Halm EA. Ethnic disparities in the treatment of stage I non-small cell lung cancer. Am J Respir Crit Care Med. 2005 May 15;171(10):1158-63. Epub 2005 Feb 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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