Danish Vulva Cancer Recurrence Study
NCT Number: NCT06495554
Acronym: DaVulvaRec
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vulva Cancer|Vulva Neoplasm|Vulvar Cancer|Vulva Disease|Vulvar Neoplasms|Vulvar Diseases|PROM|Circulating Tumor DNA|Survivorship
Interventions: DIAGNOSTIC_TEST: Measurement of circulating tumor-DNA|OTHER: Collection of patient-reported outcomes|OTHER: Algorithmically determined telephone interview with a nurse
Sponsor: University of Aarhus
Collaborators: Aarhus University Hospital|Danish Cancer Society|Danish Comprehensive Cancer Center|Rigshospitalet, Denmark
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1295
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2032-12-31
Locations: Aarhus University Hospital, Aarhus N, 8200, Denmark

Summary:
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:

* All patients with VC will have specific tumor markers in the primary tumor that will be detectable in liquid biopsies as ctDNA at the time of diagnosis.
* Measurement of ctDNA after primary treatment and during surveillance will allow detection of residual disease, improve allocation for adjuvant treatment, and will allow early detection of recurrent VC.
* Proactive use of repeated PROM assessments in combination with procedural actions during surveillance will allow early detection of recurrent VC and early identification of late effects after treatment.

Primary Outcome Measures: Recurrence-free survival, Two years|Overall survival, Two years
Secondary Outcome Measures: Symptomatology preceding a recurrence, Two years|Improved quality-of-life as a result of proactive management of late effects on an individual level, Two years|Improved survival as a result of proactive management of late effects on group level, Two years|ctDNA detection at time of diagnosis in relation to disease stage, Two years|ctDNA detection after end of treatment in relation to residual disease, Two years|ctDNA detection during surveillance in relation to recurrent disease, Two years