Early detection of relapse in ovarian cancer using home-sampling and a multiplex protein biomarker test - The FOLL-OV trial

Purpose/aims There is no consensus on optimal follow-up after epithelial ovarian cancer (EOC). A recent RCT demonstrated eight months prolonged survival in patients with complete surgical resection.

Hence, it is crucial to detect relapses early, when the tumor burden is limited.We have identified a plasma protein panel for EOC diagnosis and follow-up.

The aim with this feasibility study is to validate the panel for its capacity to detect early relapse in symptom-free patients in a user-friendly non-invasive way i.e. a home-administered capillary sampling. On the same time we will prepare for a national prospective RCT.

Methods The feasibility study will be designed as a prospective cohort study including women in the control program after EOC in Uppsala. The study participants should have no evidence of disease after primary treatment or after relapse.

In addition to standard follow-up, they will be asked to take a capillary home-sample (using a well proven device (https://capitainer.com)) every second month during one year or until relapse. The result of the test will not affect treatment, but solely be used for research purposes.

Importance The study aims to clarify following issues before the national RCT: 1) Calibration of the risk score in capillary blood samples. 2) Evaluation of the logistics in home-sampling. 3.) Evaluation of the acceptability (reasons of drop-out etc.) of home-sampling by structured interviews of a sample of study participants.