Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 2:40 PM
Study NCT ID:
NCT01255150
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2010-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04-29', 'completionDateStruct': {'date': '2015-04-29'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2010-12-04', 'studyFirstSubmitQcDate': '2010-12-04', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of EGFR mutations in Hispanic/Latinos with nonsmall cell lung cancer according to gender and smoking status', 'timeFrame': 'At tissue and data acquisition upon enrollment'}, {'measure': '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', 'timeFrame': 'At tissue and data acquisition upon enrollment'}]}, 'conditionsModule': {'keywords': ['Genetic Ancestry Analysis', 'Molecular Profiling', 'Smoking Status', 'Wood Smoke Exposure', 'EGFR Mutation Analysis', 'Non Small Cell Lung Cancer'], 'conditions': ['Non-Small-Cell Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '19153319', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15735053', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12230422', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\n\\- 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.\n\nObjectives:\n\n\\- To study the frequency of Epidermal Growth Factor Receptor mutations in Hispanic/Latino individuals who have been diagnosed with non-small cell lung cancer.\n\nEligibility:\n\n\\- 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.\n\nDesign:\n\n* Participants will provide consent for researchers to examine lung tissue collected from a previous biopsy or surgery.\n* Treatment will not be provided as part of this protocol.', 'detailedDescription': 'Background:\n\n* 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.\n* 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.\n* However, there is no data on the frequency of EGFR mutations in U.S. Hispanic and Latin American patients with NSCLC.\n\nPrimary Protocol Objectives:\n\n* To determine the frequency of EGFR mutations in Hispanic/Latinos with non-small cell lung cancer according to gender and smoking status.\n* 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.\n\nSecondary Protocol Objectives:\n\n-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.\n\nEligibility:\n\n* Hispanic or Latino patients with histologically confirmed non-small cell lung cancer.\n* Tissue samples from Hispanic or Latino individuals with histologically confirmed non-small cell lung cancer\n\nDesign:\n\n* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nHispanic or Latino\\* patients with histologically confirmed non-small cell lung cancer.\n\nHispanic or Latino\\* patients with histologically confirmed non-small cell lung cancer.\n\n\\* 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.\n\nTumor samples from deceased Hispanic or Latino individuals with histologically confirmed non-small cell lung cancer for which basic clinical information is available\n\nPathological 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.\n\nEXCLUSION CRITERIA:\n\nPatients born in Europe, Asia, Africa or Australia are excluded.'}, 'identificationModule': {'nctId': 'NCT01255150', 'briefTitle': 'Frequency of EGFR Mutations in Latinos/Hispanics With Non-Small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Frequency of Epidermal Growth Factor Receptor Mutations in Latinos/Hispanics With Non-Small Lung Cancer', 'orgStudyIdInfo': {'id': '110044'}, 'secondaryIdInfos': [{'id': '11-C-0044'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '45429', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kettering Health Network', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Sciences Universtiy Cancer Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Cochabamba', 'country': 'Bolivia', 'facility': 'Universidad Mayor de San Simon', 'geoPoint': {'lat': -17.38195, 'lon': -66.15995}}, {'zip': '28040', 'city': 'Colima', 'country': 'Mexico', 'facility': 'Universidad de Colima', 'geoPoint': {'lat': 19.24473, 'lon': -103.7127}}, {'zip': '14080', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cancerologia', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64460', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Center for Research & Development in Health Sciences', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Querétaro', 'country': 'Mexico', 'facility': 'Universidad Autonoma de Queretaro', 'geoPoint': {'lat': 15.83752, 'lon': -92.75774}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto Nacional de Enfermedades Neoplasicas (INEN)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Instituto de Oncologia Luis Razetti', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}], 'overallOfficials': [{'name': 'Arun Rajan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}