The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer

What this Trial Is About

Researchers are investigating the best ways to detect recurrence in women with vulva cancer. This Danish nationwide multicenter study aims to improve treatment and follow-up programs by combining patient-reported outcomes with clinical data. The team also plans to explore if circulating tumor-DNA ctDNA can be found in blood samples, which may help identify early signs of cancer returning. The study includes 295 patients in the clinical group and compares results to a historical control group of 1,000 patients diagnosed between 2011 and 2022. All participants will undergo regular collection of patient-reported outcome measures every four months during their surveillance period, along with liquid biopsies to measure ctDNA at baseline and throughout follow-up. Based on patient responses, nurse telephone interviews will be conducted using an algorithm to guide care. The historical control group data will be obtained from the Danish Gynecological Cancer Database for comparison. The study is non-randomized and open-label. Participants will be followed for up to two years or until cancer recurrence. Data collected will include symptom reports, ctDNA levels, and procedural actions taken during their care pathway. The study will assess recurrence-free survival and overall survival over two years, along with quality of life and symptom management. This comprehensive monitoring aims to detect relapse early and improve management of late effects from treatment.

Danish Vulva Cancer Recurrence Study