Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer
NCT ID: NCT01255150
Last Updated: 2019-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
15 participants
OBSERVATIONAL
2010-12-01
2015-04-29
Brief Summary
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\- 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.
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Detailed Description
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* 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.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Eligibility Criteria
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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
2 Years
100 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Arun Rajan, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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Denver Health Medical Center
Denver, Colorado, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Kettering Health Network
Kettering, Ohio, United States
Oregon Health and Sciences Universtiy Cancer Center
Portland, Oregon, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Universidad Mayor de San Simon
Cochabamba, , Bolivia
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
Querétaro, , Mexico
Instituto Nacional de Enfermedades Neoplasicas (INEN)
Lima, , Peru
Instituto de Oncologia Luis Razetti
Caracas, , Venezuela
Countries
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References
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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.
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. doi: 10.1164/rccm.200411-1475OC. Epub 2005 Feb 25.
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. doi: 10.1001/archinte.162.17.1985.
Other Identifiers
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11-C-0044
Identifier Type: -
Identifier Source: secondary_id
110044
Identifier Type: -
Identifier Source: org_study_id
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