Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-01 @ 10:11 AM
Study NCT ID:
NCT01696968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2012-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Screening for Lung Cancer in Older Patients (PLCO Screening Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D019047', 'term': 'Phantoms, Imaging'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pinskyp@mail.nih.gov', 'phone': '301-496-8544', 'title': 'Paul F. Pinsky, Ph.D.', 'organization': 'Early Detection Research Group, NCI, NIH'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During each annual screening visit.', 'description': 'These events are solely those prompted by the screening examination.', 'eventGroups': [{'id': 'EG000', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.', 'otherNumAtRisk': 77445, 'otherNumAffected': 0, 'seriousNumAtRisk': 77445, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lung Cancer Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77456', 'groupId': 'OG000'}, {'value': '77445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1230', 'groupId': 'OG000'}, {'value': '1213', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Deaths From All Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77456', 'groupId': 'OG000'}, {'value': '77445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '11061', 'groupId': 'OG000'}, {'value': '10827', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Deaths from all causes were compared between the lung screening arm and the usual care arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Death Rates From All Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77456', 'groupId': 'OG000'}, {'value': '77445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '128.1', 'groupId': 'OG000'}, {'value': '125.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.00', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.', 'unitOfMeasure': 'Deaths per 10,000 PY', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Lung Cancer Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77456', 'groupId': 'OG000'}, {'value': '77445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1620', 'groupId': 'OG000'}, {'value': '1696', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Lung cancer diagnoses confirmed by medical record abstraction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Lung Cancer Incidence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77456', 'groupId': 'OG000'}, {'value': '77445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '20.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.12', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.', 'unitOfMeasure': 'Diagnoses per 10,000 PY', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Complications of Diagnostic Evaluation Following a Positive Screening Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12889', 'groupId': 'OG000'}]}, {'units': 'Positive Screens with Follow-up', 'counts': [{'value': '17475', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'title': 'When DE Led to Lung Cancer Diagnosis', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}]}]}, {'title': 'When DE Did Not Lead to Lung Cancer Diagnosis', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One year from screening examination', 'description': 'Number of positive screens with complications.', 'unitOfMeasure': 'Positive screens w/ complications', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Positive Screens with Follow-up', 'denomUnitsSelected': 'Positive Screens with Follow-up', 'populationDescription': 'The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.'}, {'type': 'SECONDARY', 'title': 'T0 (Baseline) CXR Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67037', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '61009', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '5965', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T0 (at study entry)', 'description': 'Postero-anterior view chest radiograph (CXR) result', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T1 CXR Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64706', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '60015', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '4614', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T1 (one year after entry)', 'description': 'Postero-anterior view chest radiograph (CXR) result', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.'}, {'type': 'PRIMARY', 'title': 'Lung Cancer Death Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77456', 'groupId': 'OG000'}, {'value': '77445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}, {'value': '14.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.', 'unitOfMeasure': 'Deaths per 10,000 PY', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'T2 CXR Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63305', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '59080', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '4157', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T2 (two years after entry)', 'description': 'Postero-anterior view chest radiograph (CXR) result', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T3 CXR Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41403', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '38450', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '2908', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T3 (three years after entry)', 'description': 'Postero-anterior view chest radiograph (CXR) result', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'FG001', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77456'}, {'groupId': 'FG001', 'numSubjects': '77445'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76255'}, {'groupId': 'FG001', 'numSubjects': '70633'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1201'}, {'groupId': 'FG001', 'numSubjects': '6812'}]}], 'dropWithdraws': [{'type': 'Cancer Before Rand. (Lung Screening)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Died Before Randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Died Before ASU (Control)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Refused ASU (Control)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '920'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Refused Screen (Lung Screening)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6796'}]}]}], 'recruitmentDetails': 'Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).', 'preAssignmentDetails': 'Participants signed a study informed consent prior to being randomized to a study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77456', 'groupId': 'BG000'}, {'value': '77445', 'groupId': 'BG001'}, {'value': '154901', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'BG001', 'title': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49612', 'groupId': 'BG000'}, {'value': '49634', 'groupId': 'BG001'}, {'value': '99246', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '27844', 'groupId': 'BG000'}, {'value': '27811', 'groupId': 'BG001'}, {'value': '55655', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39111', 'groupId': 'BG000'}, {'value': '39105', 'groupId': 'BG001'}, {'value': '78216', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38345', 'groupId': 'BG000'}, {'value': '38340', 'groupId': 'BG001'}, {'value': '76685', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '77456', 'groupId': 'BG000'}, {'value': '77445', 'groupId': 'BG001'}, {'value': '154901', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154901}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1993-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2012-09-28', 'resultsFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-06-19', 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Cancer Deaths', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.'}, {'measure': 'Lung Cancer Death Rates', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.'}], 'secondaryOutcomes': [{'measure': 'Deaths From All Causes', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Deaths from all causes were compared between the lung screening arm and the usual care arm.'}, {'measure': 'Death Rates From All Causes', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.'}, {'measure': 'Lung Cancer Incidence', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Lung cancer diagnoses confirmed by medical record abstraction.'}, {'measure': 'Lung Cancer Incidence Rates', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.'}, {'measure': 'Complications of Diagnostic Evaluation Following a Positive Screening Test', 'timeFrame': 'One year from screening examination', 'description': 'Number of positive screens with complications.'}, {'measure': 'T0 (Baseline) CXR Screening Results', 'timeFrame': 'T0 (at study entry)', 'description': 'Postero-anterior view chest radiograph (CXR) result'}, {'measure': 'T1 CXR Screening Results', 'timeFrame': 'T1 (one year after entry)', 'description': 'Postero-anterior view chest radiograph (CXR) result'}, {'measure': 'T2 CXR Screening Results', 'timeFrame': 'T2 (two years after entry)', 'description': 'Postero-anterior view chest radiograph (CXR) result'}, {'measure': 'T3 CXR Screening Results', 'timeFrame': 'T3 (three years after entry)', 'description': 'Postero-anterior view chest radiograph (CXR) result'}]}, 'conditionsModule': {'conditions': ['Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '41261199', 'type': 'DERIVED', 'citation': 'Malcomson FC, Shams-White MM, Reedy J, Huang WY, Moore SC, Loftfield E. Adherence to the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations and risk of lifestyle-related cancers in the prostate, lung, colorectal, and ovarian cancer screening trial. BJC Rep. 2025 Nov 19;3(1):81. doi: 10.1038/s44276-025-00195-6.'}, {'pmid': '38741776', 'type': 'DERIVED', 'citation': 'Fan Z, Zhang Y, Yao Q, Liu X, Duan H, Liu Y, Sheng C, Lyu Z, Yang L, Song F, Huang Y, Song F. Effects of joint screening for prostate, lung, colorectal, and ovarian cancer - results from a controlled trial. Front Oncol. 2024 Apr 29;14:1322044. doi: 10.3389/fonc.2024.1322044. eCollection 2024.'}, {'pmid': '35658861', 'type': 'DERIVED', 'citation': 'You D, Wang D, Wu Y, Chen X, Shao F, Wei Y, Zhang R, Lange T, Ma H, Xu H, Hu Z, Christiani DC, Shen H, Chen F, Zhao Y. Associations of genetic risk, BMI trajectories, and the risk of non-small cell lung cancer: a population-based cohort study. BMC Med. 2022 Jun 6;20(1):203. doi: 10.1186/s12916-022-02400-6.'}, {'pmid': '34548240', 'type': 'DERIVED', 'citation': 'Jiang Y, Xie Q, Chen R. Breast Cancer Incidence and Mortality in Relation to Hormone Replacement Therapy Use Among Postmenopausal Women: Results From a Prospective Cohort Study. Clin Breast Cancer. 2022 Feb;22(2):e206-e213. doi: 10.1016/j.clbc.2021.06.010. Epub 2021 Jun 26.'}, {'pmid': '33277073', 'type': 'DERIVED', 'citation': 'Wang K, Wu Q, Li Z, Reger MK, Xiong Y, Zhong G, Li Q, Zhang X, Li H, Foukakis T, Xiang T, Zhang J, Ren G. Vitamin K intake and breast cancer incidence and death: results from a prospective cohort study. Clin Nutr. 2021 May;40(5):3370-3378. doi: 10.1016/j.clnu.2020.11.009. Epub 2020 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine whether screening with chest x-ray can reduce mortality from lung cancer in women and men aged 55-74 at entry.\n\nSECONDARY OBJECTIVES:\n\nI. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.\n\nII. To assess the incidence, stage, and survival of cancer cases. III. To investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints.\n\nIV. To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors.\n\nOUTLINE: Participants in the overall PLCO study are stratified by screening center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms (control vs screening).\n\nARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline.\n\nARM II (Lung Screening): Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal lung cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with lung cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy.\n\nParticipants complete a Baseline Questionnaire (BQF/M) to assess smoking status. Participants complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update (ADU) (previously referred to as the Periodic Survey of Health \\[PSH\\] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident lung cancers as all deaths that occur among both screened and control subjects during the trial.\n\nAfter completion of screening, participants are followed up for at least 13 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age\n* Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer\n* Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or ovary (women only)\n\n * This includes primary or metastatic PLCO cancers\n* Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only)\n\n * Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason.\n* Individuals who are participating in another cancer screening or cancer primary prevention trial\n* Males who have taken Proscar/Propecia/finasteride in the past 6 months\n\n * NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride.\n * NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial.\n * Prior to April 1, 1999 women were excluded from the trial if they were currently taking or had taken Tamoxifen or Evista\\\\Raloxifene in the past 6 months. As of April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have or are currently taking Tamoxifen or Evista\\\\Raloxifene are not excluded from participation.\n* Individuals who are unwilling or unable to sign the informed consent form\n* Males who have had more than one PSA blood test in the past three years\n* Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years'}, 'identificationModule': {'nctId': 'NCT01696968', 'briefTitle': 'Screening for Lung Cancer in Older Patients (PLCO Screening Trial)', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial', 'orgStudyIdInfo': {'id': 'NCI-2012-01756'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01756', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000078532'}, {'id': 'NCI-P93-0050'}, {'id': 'PLCO-1'}, {'id': 'PLCO-Lung', 'type': 'OTHER', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants receive standard medical care. Participants complete a DHQ at baseline.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lung Screening', 'description': 'Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as "smokers" undergo an additional chest x-ray at year 3. Participants complete a BQF/M at baseline. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident lung cancers as all deaths that occur among both screened and control subjects during the trial.', 'interventionNames': ['Other: Screening Questionnaire Administration', 'Procedure: X-Ray Imaging']}], 'interventions': [{'name': 'Screening Questionnaire Administration', 'type': 'OTHER', 'description': 'Undergo questionnaire assessments', 'armGroupLabels': ['Lung Screening']}, {'name': 'X-Ray Imaging', 'type': 'PROCEDURE', 'otherNames': ['Conventional X-Ray', 'Diagnostic Radiology', 'Medical Imaging, X-Ray', 'Plain film radiographs', 'Radiographic Imaging', 'Radiographic imaging procedure (procedure)', 'Radiography', 'RG', 'Static X-Ray', 'X-Ray'], 'description': 'Undergo a chest x-ray', 'armGroupLabels': ['Lung Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Christine D Berg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}