Clinical trial Recruiting at 2 sites Interventional Ages 18 and up Women only

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment1295 (estimated)
SponsorUniversity of Aarhus
Academic / other
Locations2 sites (Aarhus N and 1 other locations)
StatusRecruiting
StartedAugust 15, 2024
Main results expectedDecember 31, 2028
Study endsDecember 31, 2030
Registry record updatedApril 29, 2026
Trial IDNCT06495554 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.