Investigation of recurrence detection in vulva cancer patients
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
Run by University of Aarhus · NCT06495554 · Data updated 2026-11-12
This study is testing how well doctors can detect if vulva cancer comes back in women by looking at their symptoms and checking for cancer DNA in their blood over two years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1295 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus N and 1 other locations) |
| Status | Recruiting |
| Started | August 15, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT06495554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women aged 18 and older with biopsy-verified squamous cell carcinoma of the vulva.
✕Probably not a fit
Patients currently undergoing treatment for other concurrent cancers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to explore various aspects of recurrence detection in women diagnosed with vulva cancer. It is a nationwide multicenter initiative in Denmark that will collect patient-reported outcomes and procedural data to evaluate symptoms and actions taken from the initial diagnosis to recurrence. Additionally, the study will investigate the presence of circulating tumor-DNA in liquid biopsies from patients. Participants will be monitored for two years or until recurrence, with regular assessments every four months.
Why it matters
Potential benefit: If successful, this study could lead to improved surveillance and treatment strategies for vulva cancer patients, enhancing early detection of recurrence.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in utilizing liquid biopsies for cancer detection.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Aarhus University Hospital
Aarhus N, Denmark Recruiting -
Copenhagen University Hospital
Copenhagen, Denmark Recruiting
Study contacts
- Principal investigator: Pernille T. Jensen, Professor — Aarhus University Hospital
- Study coordinator: Louise Krog, BSc.med.
- Email: loukrg@rm.dk
- Phone: 20995607
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.