NCT06495554

Danish Vulva Cancer Recurrence Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,295 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulva Cancer
• Vulva Neoplasm
• Vulvar Cancer
• Vulva Disease
• Vulvar Neoplasms
• Vulvar Diseases
• PROM
• Circulating Tumor DNA
• Survivorship

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Measurement of circulating tumor-DNA	Liquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA.
OTHER	Collection of patient-reported outcomes	Patient-reported outcomes will be collected at baseline and prospectively during follow-up.
OTHER	Algorithmically determined telephone interview with a nurse	Dependent on the patient's responses on the patient-reported outcome measures.

Timeline

• Start date: 2024-08-15
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2024-07-10
• Last updated: 2024-11-15

Locations

2 sites across 1 country: Denmark