Danish Vulva Cancer Recurrence Study

NCT06495554 | Recruiting

• 1 other identifier: 1-10-72-150-23
• Study Type: interventional
• Target: 1,295
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Recurrence-free survival

  Two years

• Overall survival

  Two years

Secondary Outcomes (6)

• 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

Study Arms (2)

PROM assessment and ctDNA detection during surveillance

EXPERIMENTAL

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

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

Standard surveillance

NO INTERVENTION

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

Interventions

Algorithmically determined telephone interview with a nurse OTHER

Dependent on the patient's responses on the patient-reported outcome measures.

PROM assessment and ctDNA detection during surveillance

Measurement of circulating tumor-DNA DIAGNOSTIC_TEST

Liquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA.

PROM assessment and ctDNA detection during surveillance

Collection of patient-reported outcomes OTHER

Patient-reported outcomes will be collected at baseline and prospectively during follow-up.

PROM assessment and ctDNA detection during surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva
• ≥ 18 years of age
• Able to understand oral and written information in Danish

You may not qualify if:

• Active treatment for concurrent cancer and/or dissemination of concurrent cancer

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Danish Cancer Society: collaborator
• Danish Comprehensive Cancer Center: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms; Vulvar Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Pernille T. Jensen, Professor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Krog, BSc.med.

CONTACT

20995607; loukrg@rm.dk

Pernille T. Jensen, Professor

CONTACT

20952061; petije@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 10, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)