An interventional study of Measurement of circulating tumor-DNA and Collection of patient-reported outcomes in Vulva Cancer, Vulva Neoplasm and Vulvar Cancer, sponsored by University of Aarhus. Recruiting at 2 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of Aarhus · Not applicable, Interventional, and Other
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:
236 studies on the registry are indexed under Vulvar Neoplasms; 69 are open to participants now.
This study's planned enrollment of 1,295 is above the median of 59 across 168 interventional studies indexed under Vulvar Neoplasms.
Browse Vulvar Neoplasms studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants (n=295) included in the prospective clinical study
Diagnostic Test: Measurement of circulating tumor-DNA · Other: Collection of patient-reported outcomes · Other: Algorithmically determined telephone interview with a nurse
Historical controls (n=1,000) who will be identified by the Danish Gynecological Cancer Database
Liquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA.
Patient-reported outcomes will be collected at baseline and prospectively during follow-up.
Dependent on the patient's responses on the patient-reported outcome measures.
Recurrence-free survival
Time frame: Two years
Overall survival
Time frame: Two years
Symptomatology preceding a recurrence
Time frame: Two years
Improved quality-of-life as a result of proactive management of late effects on an individual level
Time frame: Two years
Improved survival as a result of proactive management of late effects on group level
Time frame: Two years
ctDNA detection at time of diagnosis in relation to disease stage
Time frame: Two years
ctDNA detection after end of treatment in relation to residual disease
Time frame: Two years
ctDNA detection during surveillance in relation to recurrent disease
Time frame: Two years
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Dec 2028, 52 months after the start.
Of 43 non-industry interventional studies with no phase under Vulvar Neoplasms, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 129. This study's planned 52 months is above that.
Counting every sponsor, half of 43 studies reached it within 28 months; a quarter within 17 and three quarters within 129.
How these figures are worked out, and which studies are left out of them.
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