Biomarkers for ovarian cancer risk assessment

Utility of biomarkers for ovarian cancer risk assessment in primary care: a pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13470572

Enrollment

1200

Registered

2018-06-13

Start date

2018-04-03

Completion date

Unknown

Last updated

2022-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer Cancer Malignant neoplasm of ovary

Interventions

Study setting: Central Manchester University Hospitals NHS Foundation Trust (CMFT). This centre receives around 900 CA125 samples from primary care each year. Study duration: Total: 2

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Phase 1: 1. Women undergoing GP requested CA125 testing where the sample is processed by MFT 2. Aged over 18 Phase 2: 1. Women who underwent initial CA125 and HE4 testing in phase 1 who are subsequently referred for further tests or treatment 2. Ability to provide informed consent 3. Aged over 18 years

Exclusion criteria

Exclusion criteria: Phase 2: Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Specificity of HE4, at different cut off thresholds, alone and in combination with CA125 for ovarian cancer detection in a symptomatic primary care population	—

Secondary

Measure	Time frame
1. Sensitivity of HE4 at different cut off thresholds, alone or in combination with CA125 for ovarian cancer detection in a symptomatic primary care population 2. ELISA versus lumipulse HE4 levels	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026