TriangleNCT01696994 · STUDY IN CONTEXT
Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.
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.
Ovarian cancer diagnoses confirmed by medical record abstraction.
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.
Number of positive screens with complications
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- trial label
- Screening for Ovarian Cancer in Older Patients (PLCO Screening Trial)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0000
- source section id
- NCT01696994-om-0000
- source outcome index
- 0
- endpoint
- Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)
- endpoint definition
- Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.
- time origin
- Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0001
- source section id
- NCT01696994-om-0001
- source outcome index
- 1
- endpoint
- Deaths From All Causes
- endpoint definition
- Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.
- time origin
- Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0002
- source section id
- NCT01696994-om-0002
- source outcome index
- 2
- endpoint
- Death Rates From All Causes
- endpoint definition
- 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.
- time origin
- Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0003
- source section id
- NCT01696994-om-0003
- source outcome index
- 3
- endpoint
- Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)
- endpoint definition
- Ovarian cancer diagnoses confirmed by medical record abstraction.
- time origin
- Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0004
- source section id
- NCT01696994-om-0004
- source outcome index
- 4
- endpoint
- Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).
- endpoint definition
- 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.
- time origin
- Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0005
- source section id
- NCT01696994-om-0005
- source outcome index
- 5
- endpoint
- Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test
- endpoint definition
- Number of positive screens with complications
- time origin
- One year from screening examination
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Control
- regimen
- Participants receive standard medical care.
- analyzed count
- 34304
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Ovarian Screening
- regimen
- 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.
- analyzed count
- 34253
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Control
- regimen
- Participants receive standard medical care.
- analyzed count
- 34304
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Ovarian Screening
- regimen
- 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.
- analyzed count
- 34253
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Control
- regimen
- Participants receive standard medical care.
- analyzed count
- 34304
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Ovarian Screening
- regimen
- 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.
- analyzed count
- 34253
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Control
- regimen
- Participants receive standard medical care.
- analyzed count
- 34304
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Ovarian Screening
- regimen
- 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.
- analyzed count
- 34253
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Control
- regimen
- Participants receive standard medical care.
- analyzed count
- 34304
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Ovarian Screening
- regimen
- 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.
- analyzed count
- 34253
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Ovarian Screening
- regimen
- 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.
- analyzed count
- 3531
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01696994-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ovarian-germ-cell-tumors
- nct id
- NCT01696994
- harm key
- EG000
- source section id
- NCT01696994-ae
- event group key
- EG000
- event group label
- Ovarian Screening
- serious affected
- 0
- serious at risk
- 34253
- other affected
- 903
- other at risk
- 34253
- frequency threshold
- 0
- collection period
- During each annual screening visit.
- event definition
- These events are solely those prompted by the screening examination.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice