Clinical trial NCT06495554: Danish Vulva Cancer Recurrence Study
Official title: The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulva Cancer
Vulva Neoplasm
Vulvar Cancer
Vulva Disease
Vulvar Neoplasms
Vulvar Diseases
PROM
Circulating Tumor DNA
Survivorship
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Danish Cancer Society
name: Danish Comprehensive Cancer Center
name: Rigshospitalet, Denmark
First posted: 2024-07-10
Enrollment: 1295
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence-free survival
timeFrame: Two years
measure: Overall survival
timeFrame: Two years
Secondary outcomes:
measure: Symptomatology preceding a recurrence
timeFrame: Two years
measure: Improved quality-of-life as a result of proactive management of late effects on an individual level
timeFrame: Two years
measure: Improved survival as a result of proactive management of late effects on group level
timeFrame: Two years
measure: ctDNA detection at time of diagnosis in relation to disease stage
timeFrame: Two years
measure: ctDNA detection after end of treatment in relation to residual disease
timeFrame: Two years
measure: ctDNA detection during surveillance in relation to recurrent disease
timeFrame: Two years
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Pernille T. Jensen, Professor
role: PRINCIPAL_INVESTIGATOR
References: