Danish Vulva Cancer Recurrence Study (DaVulvaRec)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vulvar Cancer; Vulvar Neoplasms; Vulvar Diseases; Survivorship; Circulating Tumor DNA; PROM; Vulva Cancer; Vulva Neoplasm; Vulva Disease
• Intervention / Treatment: Diagnostic test: Measurement of circulating tumor-DNA; Other: Collection of patient-reported outcomes; Other: Algorithmically determined telephone interview with a nurse

• Study Type: Interventional
• Enrollment (Estimated): 1295
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louise Krog, BSc.med.; Phone Number: +45 20995607; Email: loukrg@rm.dk
• Study Contact Backup: Name: Pernille T. Jensen, Professor; Phone Number: +45 20952061; Email: petije@rm.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Louise Krog, BSc.med.; Phone Number: +4520995607; Email: loukrg@rm.dk
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Copenhagen University Hospital
    • Contact: Ligita Frøding, MD; Phone Number: +4522722972; Email: ligita.paskeviciute.froeding@regionh.dk
    • Contact: Louise Krog; Phone Number: +4520995607; Email: loukrg@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROM assessment and ctDNA detection during surveillance; All participants (n=295) included in the prospective clinical study	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.
No Intervention: Standard surveillance; Historical controls (n=1,000) who will be identified by the Danish Gynecological Cancer Database

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Two years
Recurrence-free survival	Two years

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Rigshospitalet, Denmark; Danish Cancer Society; Danish Comprehensive Cancer Center
• Investigators: Principal Investigator: Pernille T. Jensen, Professor, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Genital Neoplasms, Female; Vulvar Neoplasms; Vulvar Diseases
• Other Study ID Numbers: 1-10-72-150-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No