Danish Vulva Cancer Recurrence Study
- Conditions
- Vulva CancerVulva DiseaseVulvar NeoplasmsSurvivorshipVulva NeoplasmCirculating Tumor DNAVulvar CancerVulvar DiseasesPROM
- Interventions
- Diagnostic Test: Measurement of circulating tumor-DNAOther: Collection of patient-reported outcomesOther: Algorithmically determined telephone interview with a nurse
- Registration Number
- NCT06495554
- Lead Sponsor
- University of Aarhus
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1295
- Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva
- ≥ 18 years of age
- Able to understand oral and written information in Danish
- Active treatment for concurrent cancer and/or dissemination of concurrent cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PROM assessment and ctDNA detection during surveillance Measurement of circulating tumor-DNA All participants (n=295) included in the prospective clinical study PROM assessment and ctDNA detection during surveillance Collection of patient-reported outcomes All participants (n=295) included in the prospective clinical study PROM assessment and ctDNA detection during surveillance Algorithmically determined telephone interview with a nurse All participants (n=295) included in the prospective clinical study
- Primary Outcome Measures
Name Time Method Recurrence-free survival Two years Overall survival Two years
- Secondary Outcome Measures
Name Time Method Improved survival as a result of proactive management of late effects on group level 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 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 ctDNA detection at time of diagnosis in relation to disease stage Two years
Trial Locations
- Locations (2)
Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Aarhus University Hospital
🇩🇰Aarhus N, Denmark