Non-Small-Cell Lung CarcinomaNCT01255150
Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer
An observational study of Non-Small-Cell Lung Carcinoma, run by National Cancer Institute (NCI) at 12 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- How many people
- 15 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 1 Dec 2010to 29 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients born in Europe, Asia, Africa or Australia are excluded.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
United States5 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Denver Health Medical Center
Denver, Colorado, 80204
Kettering Health Network
Kettering, Ohio, 45429
Oregon Health and Sciences Universtiy Cancer Center
Portland, Oregon, 97239
Mexico4 sites
Universidad de Colima
Colima, 28040
Instituto Nacional de Cancerologia
Mexico City, 14080
Center for Research & Development in Health Sciences
Monterrey, 64460
Universidad Autonoma de Queretaro
Querétaro
About this study
Official title: 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.
Read more
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.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Genetic Ancestry Analysis, Molecular Profiling, Smoking Status, Wood Smoke Exposure, EGFR Mutation Analysis, Non Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of EGFR mutations in Hispanic/Latinos with nonsmall cell lung cancer according to gender and smoking status
Measured: 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
Measured: At tissue and data acquisition upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study start1 Dec 2010
- Study completion29 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Arun Rajan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255150
- Sponsor's protocol ID
- 110044
- Other IDs
- 11-C-0044
- Status last verified
- 29 Apr 2015
- First submitted
- 4 Dec 2010
- Last updated
- 21 Nov 2019
- Results posted
- No
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 19153319Wisnivesky 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 15735053Clegg 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Epidermal Growth Factor Receptor Mutations in Latinos/Hispanics With Non-Small Lung Cancer
- ClinicalTrials.gov ID
- NCT01255150
- Acronym / sponsor ID
- 110044
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Genetic Ancestry Analysis, Molecular Profiling, Smoking Status, Wood Smoke Exposure, EGFR Mutation Analysis, Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Dec 2010
- Study completion
- 29 Apr 2015
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients born in Europe, Asia, Africa or Australia are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 19153319Farjah 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.
- Background: PubMed 15735053Wisnivesky 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.
- Background: PubMed 12230422Clegg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Rajan, M.D. principal investigator
National Cancer Institute (NCI)
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small-Cell Lung Carcinoma, run by National Cancer Institute (NCI) at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Mexico, Bolivia, Peru, Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01255150, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.