RecruitingNot ApplicableNCT06495554

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


Sponsor

University of Aarhus

Enrollment

1,295 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Danish study is collecting clinical data on women with vulvar cancer (a rare cancer of the outer female genitals) to better understand patterns of recurrence and improve future treatment approaches. **You may be eligible if...** - You are 18 or older - You have a biopsy-confirmed diagnosis of primary or recurrent squamous cell carcinoma of the vulva - You are able to understand spoken and written Danish **You may NOT be eligible if...** - You are currently being treated for another active cancer - Your other cancer is spreading Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMeasurement of circulating tumor-DNA

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

OTHERCollection of patient-reported outcomes

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

OTHERAlgorithmically determined telephone interview with a nurse

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


Locations(2)

Aarhus University Hospital

Aarhus N, Denmark

Copenhagen University Hospital

Copenhagen, Denmark

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NCT06495554


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