Investigation of recurrence detection in vulva cancer patients
The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1295 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus N and 1 other locations) |
| Trial ID | NCT06495554 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with biopsy-verified squamous cell carcinoma of the vulva.
Not a fit: Patients currently undergoing treatment for other concurrent cancers may not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown promise in utilizing liquid biopsies for cancer detection.
Eligibility criteria
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 this trial is running
Aarhus N and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.