Danish Vulva Cancer Recurrence Study (DaVulvaRec)

University of Aarhus

Status: Enrolling

Conditions: Vulva Neoplasm; Vulvar Cancer; Vulvar Neoplasms; Survivorship; Circulating Tumor DNA; Vulvar Diseases; PROM; Vulva Cancer; Vulva Disease

Treatments: Other: Collection of patient-reported outcomes; Other: Algorithmically determined telephone interview with a nurse; Diagnostic Test: Measurement of circulating tumor-DNA

Study type: Interventional

Funder types: Other

Identifiers

NCT06495554

1-10-72-150-23

Details and patient eligibility

About

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.

Enrollment: 1,295 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,295 participants in 2 patient groups

PROM assessment and ctDNA detection during surveillance

Experimental group

Description:

All participants (n=295) included in the prospective clinical study

Treatment:

Other: Algorithmically determined telephone interview with a nurse

Diagnostic Test: Measurement of circulating tumor-DNA

Other: Collection of patient-reported outcomes

Standard surveillance

No Intervention group

Description:

Historical controls (n=1,000) who will be identified by the Danish Gynecological Cancer Database