Circulating Tumor DNA, PROM, Survivorship, Vulva Cancer, Vulva Disease, Vulva Neoplasm, Vulvar Cancer, Vulvar Diseases, Vulvar Neoplasms
Conditions
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.
Interventions
DIAGNOSTIC_TESTMeasurement of circulating tumor-DNA
Liquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA.
OTHERCollection of patient-reported outcomes
Patient-reported outcomes will be collected at baseline and prospectively during follow-up.
OTHERAlgorithmically determined telephone interview with a nurse
Dependent on the patient's responses on the patient-reported outcome measures.
Sponsors
University of Aarhus
Aarhus University Hospital
Danish Cancer Society
Danish Comprehensive Cancer Center
Rigshospitalet, Denmark
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva * ≥ 18 years of age * Able to understand oral and written information in Danish
Exclusion criteria
* Active treatment for concurrent cancer and/or dissemination of concurrent cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival | Two years |
| Overall survival | Two years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Contacts
CONTACTLouise Krog, BSc.med.
CONTACTPernille T. Jensen, Professor
PRINCIPAL_INVESTIGATORPernille T. Jensen, Professor
Aarhus University Hospital
Outcome results
None listed