Methods
When a primary care sample with elevated CA125 is identified by the laboratory of this hospital, the biochemist’s report includes advice to consider a pelvic ultrasound scan. We arranged for these ultrasounds to be done in the main hospital radiology department rather than community sites and women were invited to consent to join the study. Serum HE4 was measured as well as CA125 in a new blood sample and medical records were reviewed. In a subsidiary study, women who had an ovarian cancer diagnosis made on a different pathway were invited to consent to having their serum HE4 measured. The analysis was by a chemiluminescent enzyme immunoassay technique using a Fujirebio Lumipulse G600II analyser. Cut-off values for HE4 of 77 and 150 pmol/l are in use[3,4].
The progress of the study was interrupted by the COVID 19 pandemic and it was not possible to arrange for all the subjects to have their ultrasounds undertaken at the hospital. The numbers we recruited were fewer than expected.