An interventional study of Measurement of circulating tumor-DNA and Collection of patient-reported outcomes in Vulva Cancer, Vulva Neoplasm and Vulvar Cancer, sponsored by University of Aarhus. Recruiting at 2 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of Aarhus · Not applicable, Interventional, and Other
The overall aim is to investigate different aspects of recurrence detection in women with vulva cancer (VC) to identify optimal treatment- and surveillance programs.
DaVulvaRec is a Danish nationwide multicenter study with patient inclusion from Aarhus University Hospital and Rigshospitalet, Denmark. Applying a mixed method research design, the investigators will collect and analyze patient-reported outcome measures in combination with procedural data to evaluate symptomatology and map actions taken during the patient's pathway from primary disease to recurrence. Furthermore, the investigators aim to examine if circulating tumor-DNA (ctDNA) can be detected in liquid biopsies from VC patients. All patients will be followed for two years or until recurrence. Patient-reported outcome measures will be completed every four months during surveillance, and liquid biopsies will be collected prospectively for later analyses.
Total number of patients to be included is 295 according to a power calculation. All patients in the clinical study will be included in the intervention group, while data on a historical control group will be obtained from The Danish Gynecological Cancer Database. Hence, the control group will consist of 1000 VC patients diagnosed between 2011-2022.
Hypotheses:
Exclusion Criteria:
All participants (n=295) included in the prospective clinical study
Diagnostic Test: Measurement of circulating tumor-DNA · Other: Collection of patient-reported outcomes · Other: Algorithmically determined telephone interview with a nurse
Historical controls (n=1,000) who will be identified by the Danish Gynecological Cancer Database
Liquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA.
Patient-reported outcomes will be collected at baseline and prospectively during follow-up.
Dependent on the patient's responses on the patient-reported outcome measures.
Recurrence-free survival
Time frame: Two years
Overall survival
Time frame: Two years
Symptomatology preceding a recurrence
Time frame: Two years
Improved quality-of-life as a result of proactive management of late effects on an individual level
Time frame: Two years
Improved survival as a result of proactive management of late effects on group level
Time frame: Two years
ctDNA detection at time of diagnosis in relation to disease stage
Time frame: Two years
ctDNA detection after end of treatment in relation to residual disease
Time frame: Two years
ctDNA detection during surveillance in relation to recurrent disease
Time frame: Two years
Plan to share: No
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University of Aarhus