Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05490251
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2022-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Translational Research Center in Lung Cancer Disparities (TRACER) Project 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-09', 'size': 410302, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-29T10:10', 'hasProtocol': True}, {'date': '2021-11-29', 'size': 214642, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-29T10:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva will be conducted for analyzing biomarkers of stress (i.e. cortisol, alpha-amylase), and biomarkers related to smoking (i.e. cotinine)\n\nUrine will be collected to determine the presence of illicit substances as an indicator of exclusion/inclusion into the study.\n\nPatients that provide consent will have additional saliva and urine collected and stored in a centralized biorepository for future research'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examining racial differences in acute stress responses', 'timeFrame': 'Within 1 month following baseline', 'description': 'Examine racial differences in acute stress responses using a validated psychological stress challenge called the Trier Social Stress Test (TSST)'}, {'measure': 'Examining changes in daily cortisol patterns according to race', 'timeFrame': 'Baseline, 4- and 8 weeks post Trier Social Stress Test laboratory visit', 'description': 'Examine racial differences in daily diurnal cortisol slopes to evaluate hypothalamic-pituitary-adrenal-axis dysregulation and acute stress'}, {'measure': 'Examine changes in stress responses and smoking behaviors as it relates to social determinant factors', 'timeFrame': 'Baseline, 4- and 8-weeks post Trier Social Stress Test laboratory visit', 'description': 'Patients will be administered a survey using validated measures to examine socioeconomic, structural, and psychosocial stressors that impact daily stress and smoking behaviors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking', 'Smoking Behaviors', 'Smoking Cessation', 'Stress Reaction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine racial differences in smoking behaviors and stress responses between African American and white male smokers.', 'detailedDescription': 'Cigarette smoking is a leading cause of morbidity and mortality from lung cancer among adults in the US. Stress relief and smoking cessation is the best preventive strategy for reducing lung cancer risk and addressing racial disparities in outcomes. Despite this, racial differences are found among those that make quit attempts. Stress has been found to be related to smoking initiation, maintenance, and relapse. Yet, differences in stress responses have not been examined between African American and white smokers. Therefore, this study will examine racial differences in stress responses and smoking behaviors between African American and white male smokers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'African American and white male daily smokers who are between the ages of 18-75 and who smoke at least 5 to 10 cigarettes per day.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American and white males\n* Between the ages of 18-75 years old\n* Smoke at least 5 to 10 cigarettes per day\n\nExclusion Criteria:\n\n* Smokers who have a serious cognitive disorder\n* Have a personal history of lung cancer\n* Personal history of usage of illicit drug and alcohol abuse\n* Enrollment in a smoking cessation treatment program during the past 6 months\n* Current use of a nicotine replacement therapy\n* Have any positive responses on the Mini International Neuropsychiatric Interview (MINI) screener'}, 'identificationModule': {'nctId': 'NCT05490251', 'acronym': 'TRACER', 'briefTitle': 'Translational Research Center in Lung Cancer Disparities (TRACER) Project 2', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Biological Pathways in Stress Reactivity and Nicotine Addiction Among African American and White Smokers', 'orgStudyIdInfo': {'id': 'MCC-21-18891'}, 'secondaryIdInfos': [{'id': '00116801', 'type': 'OTHER', 'domain': 'Medical University of South Carolina'}, {'id': 'HM20022956', 'type': 'OTHER', 'domain': 'Virginia Commonwealth University'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Robert Winn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'City of Hope Medical Center', 'class': 'OTHER'}, {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}