Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - 100 |
| Updated: | 3/20/2019 |
| Start Date: | December 1, 2010 |
| End Date: | April 29, 2015 |
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.
- 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.
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.
- 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.
- 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.
We found this trial at
6
sites
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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