Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT05898594
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Cancer Screening in High-risk Black Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Enrolled Participants', 'timeFrame': 'At enrollment', 'description': 'Primary endpoint is feasibility. Feasibility is defined as the percentage of individuals invited to participate in the trial who enroll.'}, {'measure': 'Proportion of Participants with Positive Low-dose Computed Tomography Test', 'timeFrame': 'At 3 months', 'description': 'The percentage of participants who have a positive low-dose computed tomography test will be evaluated. This percentage will be compared to the Black individuals randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control).'}, {'measure': 'Proportion of Participants Diagnosed with Invasive Lung Cancer', 'timeFrame': 'At 6 months', 'description': 'The proportion of participants with a lung cancer diagnosis post-low-dose computed tomography screening test will be compared to Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control).'}, {'measure': 'Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores', 'timeFrame': 'At 3 months', 'description': 'The distribution of Lung-RADS scores among participants will be evaluated and compared to the distribution of Lung-RADS scores among Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control).'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Who Undergo Invasive Diagnostic Procedures', 'timeFrame': 'At 6 months', 'description': 'The proportion of participants who undergo invasive diagnostic procedures will be evaluated and compared to the proportion of Black individuals randomized to the LDCT screening arm in the National Lung Screening Trial (historical control) who underwent invasive diagnostic procedures.'}, {'measure': 'Proportion of Participants Who Have a Complication Resulting from an Invasive Diagnostic Procedure Performed for a Positive Low-dose Computed Tomography Scan', 'timeFrame': 'At 6 months', 'description': 'The proportion of participants who have a complication resulting from an invasive diagnostic procedure performed for a positive low-dose computed tomography scan will be evaluated. This proportion will be compared to the proportion of Black individuals randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control) who had a complication resulting from an invasive diagnostic procedure performed for a positive low-dose computed tomography scan.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Cancer', 'Lung Carcinoma'], 'conditions': ['Lung Cancer', 'Lung Carcinoma']}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to study U.S. Black individuals with a history of smoking to examine the feasibility, acceptability, and performance of low-dose computed tomography (LDCT) screening among this population.\n\nThe name of the intervention used in this research study is:\n\nLow-dose computed tomography (radiologic scan) chest scan', 'detailedDescription': 'The goal of this single-arm pilot research study is to evaluate the feasibility and acceptability of low-dose computed tomography (LDCT) screening for lung cancer among U.S. Black individuals with a history of smoking.\n\nLDCT screening is currently the only recommended way to screen for lung cancer among high-risk individuals. However, many Black individuals at high-risk for lunch cancer are currently ineligible for lung cancer screening.\n\nStudy procedures include screening for eligibility, completion of questionnaires, and a LDCT screening test.\n\nParticipation in this study is expected to last up to 3 months.\n\nIt is expected about 900 people will participate in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identified Black individual.\n* Have a self-reported history of smoking. No restriction will be placed on the number of smoking pack years participants must have nor the number of years former smokers must have quit smoking.\n* Aged \\>= 50 years.\n\nExclusion Criteria:\n\n* Individuals with a history of lung cancer.\n* Individuals with symptoms suggestive of lung cancer. We will evaluate whether individuals have symptoms suggestive of lung cancer by administering an online screening questionnaire, which will ask whether they have experienced shortness of breath, whether they become easily winded, and whether they have had a chronic cough within the last 12 weeks that has not improved. Individuals who select that they have any one of these symptoms will be advised to follow up with their primary doctor and will not be eligible to participate in the study.\n* Individuals with pneumonia or acute respiratory infection within 12 weeks prior to enrollment that was treated with antibiotics.'}, 'identificationModule': {'nctId': 'NCT05898594', 'briefTitle': 'Lung Cancer Screening in High-risk Black Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Evaluating the Feasibility of Lung Cancer Screening in High-risk Black Individuals', 'orgStudyIdInfo': {'id': '22-382'}, 'secondaryIdInfos': [{'id': '1R18HS029430-01', 'link': 'https://reporter.nih.gov/quickSearch/1R18HS029430-01', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening: Low-Dose Computed Tomography Screening', 'description': 'Participants will undergo study procedures as outlined:\n\n* Complete questionnaires pre- and post- low-dose computed tomography (LDCT) test.\n* Visit Massachusetts General Hospital facility for a LDCT screening test.', 'interventionNames': ['Procedure: Low-dose Computed Tomography']}], 'interventions': [{'name': 'Low-dose Computed Tomography', 'type': 'PROCEDURE', 'description': 'Per standard care', 'armGroupLabels': ['Screening: Low-Dose Computed Tomography Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Donington, MD', 'role': 'CONTACT', 'email': 'jdonington@surgery.bsd.uchicago.edu', 'phone': '773-834-6121'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chi Fu Jeffrey Yang, MD', 'role': 'CONTACT', 'email': 'cjyang@mgh.harvard.edu', 'phone': '617-724-1681'}], 'facility': 'Massachusetts General Hospital Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Chi Fu Jeffrey Yang, MD', 'role': 'CONTACT', 'email': 'cjyang@mgh.harvard.edu', 'phone': '617-724-1681'}], 'overallOfficials': [{'name': 'Chi Fu Jeffrey Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \\[contact information for Sponsor Investigator or designee\\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Partners Innovations team at http://www.partners.org/innovation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chi-Fu Jeffrey Yang', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}