Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT01696994
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 Ovarian Cancer in Older Patients (PLCO Screening Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, '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': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.', 'otherNumAtRisk': 34253, 'otherNumAffected': 903, 'seriousNumAtRisk': 34253, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 27, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizzy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 82, 'numAffected': 80}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fainted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 31, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 453, 'numAffected': 446}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 292, 'numAffected': 284}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Adverse Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34253, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34304', 'groupId': 'OG000'}, {'value': '34253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Deaths From All Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34304', 'groupId': 'OG000'}, {'value': '34253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '3542', 'groupId': 'OG000'}, {'value': '3508', '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 ovarian cancer screening arm and the usual care arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death Rates From All Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34304', 'groupId': 'OG000'}, {'value': '34253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000'}, {'value': '91.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.04', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.'}], '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 ovarian cancer 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': 'Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34304', 'groupId': 'OG000'}, {'value': '34253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Ovarian cancer diagnoses confirmed by medical record abstraction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34304', 'groupId': 'OG000'}, {'value': '34253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.48', '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': 'Ovarian cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as ovarian cancer diagnoses divided by person years at risk for ovarian cancer.', 'unitOfMeasure': 'Diagnoses per 10,000 PY', 'reportingStatus': 'POSTED', 'populationDescription': 'Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3531', 'groupId': 'OG000'}]}, {'units': 'Positive Screens with Follow-up', 'counts': [{'value': '5970', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'When DE Led to Ovarian Cancer Diagnosis', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'When DE Did Not Lead to Ovarian Cancer Diagnosis', 'categories': [{'measurements': [{'value': '226', '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, she would be counted 3 times in the number of units analyzed.'}, {'type': 'SECONDARY', 'title': 'T0 (Baseline) CA-125 Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28733', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative (<35 U/mL)', 'categories': [{'measurements': [{'value': '28275', 'groupId': 'OG000'}]}]}, {'title': 'Positive (>= 35 U/mL)', 'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T0 (at study entry)', 'description': 'Cancer Antigen 125 (CA-125) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T0 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T0 (Baseline) TVU Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28477', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '26624', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '1309', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '544', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T0 (at study entry)', 'description': 'Transvaginal Ultrasound (TVU) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T0 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T1 CA-125 Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27514', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative (<35 U/mL)', 'categories': [{'measurements': [{'value': '27035', 'groupId': 'OG000'}]}]}, {'title': 'Positive (>= 35 U/mL)', 'categories': [{'measurements': [{'value': '433', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T1 (one year after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T1 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T1 TVU Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '25740', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '930', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '376', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T1 (one year after entry)', 'description': 'Transvaginal Ultrasound (TVU) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T1 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T2 CA-125 Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26555', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative (<35 U/mL)', 'categories': [{'measurements': [{'value': '26024', 'groupId': 'OG000'}]}]}, {'title': 'Positive (>= 35 U/mL)', 'categories': [{'measurements': [{'value': '480', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T2 (two years after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T2 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T2 TVU Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26048', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '24988', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '764', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '296', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T2 (one year after entry)', 'description': 'Transvaginal Ultrasound (TVU) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T2 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T3 CA-125 Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25401', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative (<35 U/mL)', 'categories': [{'measurements': [{'value': '24925', 'groupId': 'OG000'}]}]}, {'title': 'Positive (>= 35 U/mL)', 'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T3 (three years after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T3 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T3 TVU Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24949', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '23926', 'groupId': 'OG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '733', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T3 (three years after entry)', 'description': 'Transvaginal Ultrasound (TVU) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T3 were analyzed.'}, {'type': 'PRIMARY', 'title': 'Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34304', 'groupId': 'OG000'}, {'value': '34253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'OG001', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '.91', 'ciUpperLimit': '1.54', 'pValueComment': 'Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.', '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': 'Ovarian 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', 'populationDescription': 'Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.'}, {'type': 'SECONDARY', 'title': 'T4 CA-125 Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative (<35 U/mL)', 'categories': [{'measurements': [{'value': '19772', 'groupId': 'OG000'}]}]}, {'title': 'Positive (>= 35 U/mL)', 'categories': [{'measurements': [{'value': '327', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T4 (four years after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T4 were analyzed.'}, {'type': 'SECONDARY', 'title': 'T5 CA-125 Screening Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'classes': [{'title': 'Negative (<35 U/mL)', 'categories': [{'measurements': [{'value': '21788', 'groupId': 'OG000'}]}]}, {'title': 'Positive (>= 35 U/mL)', 'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000'}]}]}, {'title': 'Inadequate screen', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'T5 (five years after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T5 were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Participants receive standard medical care.'}, {'id': 'FG001', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39111'}, {'groupId': 'FG001', 'numSubjects': '39105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33919'}, {'groupId': 'FG001', 'numSubjects': '30668'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5192'}, {'groupId': 'FG001', 'numSubjects': '8437'}]}], 'dropWithdraws': [{'type': 'Cancer Before Rand. (Ovarian Screening)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Died Before Randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Died Before ASU (Control)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No Ovaries at Baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4807'}, {'groupId': 'FG001', 'numSubjects': '4851'}]}, {'type': 'Refused ASU (Control)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Refused Screen (Ovarian Screening)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3582'}]}]}], 'recruitmentDetails': 'Participants were enrolled between November 1993 and July 2001 at 10 study centers.', 'preAssignmentDetails': 'Participants signed a study informed consent prior to being randomized to a study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39111', 'groupId': 'BG000'}, {'value': '39105', 'groupId': 'BG001'}, {'value': '78216', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Participants receive standard medical care. Participants complete a baseline questionnaire (BQ) at entry and a dietary history questionnaire (DHQ) during study years 0-6.'}, {'id': 'BG001', 'title': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for Cancer Antigen 125 (CA-125) analysis at baseline and annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.'}, {'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': '25222', 'groupId': 'BG000'}, {'value': '25233', 'groupId': 'BG001'}, {'value': '50455', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '13889', 'groupId': 'BG000'}, {'value': '13872', 'groupId': 'BG001'}, {'value': '27761', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '62.5', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39111', 'groupId': 'BG000'}, {'value': '39105', 'groupId': 'BG001'}, {'value': '78216', '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': 78216}}, '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': '2014-12-04', 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.'}, {'measure': 'Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Ovarian 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 ovarian cancer 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 ovarian cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.'}, {'measure': 'Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Ovarian cancer diagnoses confirmed by medical record abstraction.'}, {'measure': 'Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).', 'timeFrame': 'Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.', 'description': 'Ovarian cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as ovarian cancer diagnoses divided by person years at risk for ovarian cancer.'}, {'measure': 'Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test', 'timeFrame': 'One year from screening examination', 'description': 'Number of positive screens with complications'}, {'measure': 'T0 (Baseline) CA-125 Screening Results', 'timeFrame': 'T0 (at study entry)', 'description': 'Cancer Antigen 125 (CA-125) result.'}, {'measure': 'T0 (Baseline) TVU Screening Results', 'timeFrame': 'T0 (at study entry)', 'description': 'Transvaginal Ultrasound (TVU) result.'}, {'measure': 'T1 CA-125 Screening Results', 'timeFrame': 'T1 (one year after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.'}, {'measure': 'T1 TVU Screening Results', 'timeFrame': 'T1 (one year after entry)', 'description': 'Transvaginal Ultrasound (TVU) result.'}, {'measure': 'T2 CA-125 Screening Results', 'timeFrame': 'T2 (two years after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.'}, {'measure': 'T2 TVU Screening Results', 'timeFrame': 'T2 (one year after entry)', 'description': 'Transvaginal Ultrasound (TVU) result.'}, {'measure': 'T3 CA-125 Screening Results', 'timeFrame': 'T3 (three years after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.'}, {'measure': 'T3 TVU Screening Results', 'timeFrame': 'T3 (three years after entry)', 'description': 'Transvaginal Ultrasound (TVU) result.'}, {'measure': 'T4 CA-125 Screening Results', 'timeFrame': 'T4 (four years after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.'}, {'measure': 'T5 CA-125 Screening Results', 'timeFrame': 'T5 (five years after entry)', 'description': 'Cancer Antigen 125 (CA-125) result.'}]}, 'conditionsModule': {'conditions': ['Ovarian Carcinoma', 'Ovarian Germ Cell Tumor']}, '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': '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 ovarian cancer. The ovarian cancer screening tests are part of a trial that addresses the screening of four cancer sites, each with their own results record: prostate (NCT00002540), lung (NCT01696968), colorectal (NCT01696981), and ovarian (NCT01696994).', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine whether screening with CA125 and transvaginal ultrasound (TVU) can reduce mortality from ovarian cancer in women 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 (Ovarian Screening): Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo an ovarian palpation exam (OVR, discontinued in December 1998) and TVU at baseline and annually for 3 years. 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 ovarian cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with ovarian 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 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 cancers of the ovaries 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': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* 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, or ovary\n\n * This includes primary or metastatic PLCO cancers\n* Individuals with previous surgical removal of the entire colon or one lung\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* 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* Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years'}, 'identificationModule': {'nctId': 'NCT01696994', 'briefTitle': 'Screening for Ovarian 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-2012-01758'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01758', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000078532'}, {'id': 'NCI-P93-0050'}, {'id': 'PLCO-1'}, {'id': 'PLCO-Ovarian', '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': 'Ovarian Screening', 'description': 'Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years. 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 cancers of the ovaries as all deaths that occur among both screened and control subjects during the trial.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Other: Screening Questionnaire Administration', 'Procedure: Ultrasound Imaging']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ovarian Screening']}, {'name': 'Screening Questionnaire Administration', 'type': 'OTHER', 'description': 'Undergo questionnaire assessments', 'armGroupLabels': ['Ovarian Screening']}, {'name': 'Ultrasound Imaging', 'type': 'PROCEDURE', 'otherNames': ['2-Dimensional Grayscale Ultrasound Imaging', '2-Dimensional Ultrasound Imaging', '2D-US', 'Ultrasonography', 'Ultrasound', 'Ultrasound Test', 'Ultrasound, Medical', 'US'], 'description': 'Undergo TVU', 'armGroupLabels': ['Ovarian 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'}}}}