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

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ClinicalTrials.gov Identifier: NCT01255150
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date December 4, 2010
First Posted Date December 7, 2010
Last Update Posted Date March 18, 2019
Study Start Date December 1, 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: June 19, 2014)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01255150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer
Official Title Frequency of Epidermal Growth Factor Receptor Mutations in Latinos/Hispanics With Non-Small Lung Cancer
Brief 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.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Non-Small-Cell Lung Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2013)
15
Original Estimated Enrollment
 (submitted: December 4, 2010)
176
Study Completion Date April 29, 2015
Primary Completion Date Not Provided
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bolivia,   Mexico,   Peru,   United States,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number NCT01255150
Other Study ID Numbers 110044
11-C-0044
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: Arun Rajan, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date April 29, 2015