Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

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.
    

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.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Keywords: Genetic Ancestry Analysis; Molecular Profiling; Smoking Status; Wood Smoke Exposure; EGFR Mutation Analysis; Non Small Cell Lung Cancer