Introduction/Background Vulva cancer (VC) is a rare disease often diagnosed in elderly, comorbid women. Despite treatment with curative intent, up to 40% will experience at least one recurrence. Knowledge on intervention and prevention of recurrence primarily relies on small retrospective studies. There is a lack of valid biomarkers for risk stratification of women with VC. Identification of circulating tumor DNA (ctDNA) represent a novel technological advancement for personalized risk assessment and treatment allocation, and systematic assessment of patient reported outcome measures (PROMs) represent a valid method for early detection of recurrence. A combined approach may pave the way for future implementation of individualized follow-up. The aim of the present PhD study is to investigate different aspects of recurrence detection in women with VC to optimize the current surveillance program.

Methodology We will conduct a prospective cohort study with a mixed method research design. We will collect and analyze quantitative PROM data and qualitative procedural data during surveillance in women with VC to evaluate symptomatology and identify warning signs which may trigger early clinical check-up. Further, we will collect liquid biopsies to conduct a proof-of-concept study to identify ctDNA in women with VC at the time of diagnosis and prospectively during surveillance.

Results Patient enrollment is expected to start in summer 2023 and will run for approximately 5 years. We expect to include 250 patients.

Conclusion Our results will contribute with new knowledge to the field of individualized surveillance programs for women with VC. In time detection of recurrence is crucial to offer curative treatment with as limited need for mutilating surgery as possible. Follow up data from the two parallel studies will investigate if a combination of PROM assessment and ctDNA monitoring at the time of diagnosis and over time improves treatment allocation, recurrence detection, survival, and quality of life.

Disclosures LDA has sponsored research agreements with C2i, AstraZeneca, Natera, Photocure, and Ferring; has an advisory/consulting role at Ferring and UroGen; and is Chairman of the Board in BioXpedia A/S. All other authors have no disclosures.