ClinicalTrials.gg
Sign In
CompletedNCT01255150Updated Nov 21, 2019

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

An observational study in Non-Small-Cell Lung Carcinoma, sponsored by National Cancer Institute (NCI). Completed at 12 sites in 5 countries. Open to participants aged 2 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-11-21.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
15
Ages
2 Years to 100 Years
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Non-Small-Cell Lung Carcinoma

Keywords

  • Genetic Ancestry Analysis
  • Molecular Profiling
  • Smoking Status
  • Wood Smoke Exposure
  • EGFR Mutation Analysis
  • Non Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's enrollment of 15 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Hispanic or Latino* patients with 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

EXCLUSION CRITERIA:

Patients born in Europe, Asia, Africa or Australia are excluded.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
15 participants (actual)
06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

12 sites
  • Denver Health Medical Center
    Denver, Colorado 80204, United States
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
  • Kettering Health Network
    Kettering, Ohio 45429, United States
  • Oregon Health and Sciences Universtiy Cancer Center
    Portland, Oregon 97239, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Universidad Mayor de San Simon
    Cochabamba, Bolivia
  • Universidad de Colima
    Colima, 28040, Mexico
  • Instituto Nacional de Cancerologia
    Mexico City, 14080, Mexico
  • Center for Research & Development in Health Sciences
    Monterrey, 64460, Mexico
  • Universidad Autonoma de Queretaro
    Queretaro, Mexico
  • Instituto Nacional de Enfermedades Neoplasicas (INEN)
    Lima, Peru
  • Instituto de Oncologia Luis Razetti
    Caracas, Venezuela
08

References and documents

Publications

  • 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. PubMed 19153319 ↗
  • 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. PubMed 15735053 ↗
  • 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. PubMed 12230422 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01255150
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 7, 2010
Start date
Dec 1, 2010
Completion
Apr 29, 2015
Last update
Nov 21, 2019

Study contacts

Arun Rajan, M.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma, Non-Small-Cell Lung →

Other studies from this sponsor

National Cancer Institute (NCI) →

Start the discussion