Vulva CancerDaVulvaRecNCT06495554
Danish Vulva Cancer Recurrence Study
A study testing Measurement of circulating tumor-DNA, Collection of patient-reported outcomes and Algorithmically determined telephone interview with a nurse in people with Vulva Cancer and Vulva Neoplasm, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulva Cancer, Vulva Neoplasm, Vulvar Cancer
- What is being tested?
- Measurement of circulating tumor-DNA, Collection of patient-reported outcomes and Algorithmically determined telephone interview with a nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,295 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Aug 2024to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva
- ≥ 18 years of age
- Able to understand oral and written information in Danish
Who cannot join
- Active treatment for concurrent cancer and/or dissemination of concurrent cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Louise Krog, BSc.med., +4520995607, loukrg@rm.dk
- Recruiting
Copenhagen University Hospital
Copenhagen, 2100
Ligita Frøding, MD, +4522722972, ligita.paskeviciute.froeding@regionh.dk
Louise Krog, +4520995607, loukrg@rm.dk
About this study
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
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.
Read more
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.
- Conditions
- Vulva Cancer, Vulva Neoplasm, Vulvar Cancer, Vulva Disease, Vulvar Neoplasms, Vulvar Diseases
- Being tested
- Measurement of circulating tumor-DNA, Collection of patient-reported outcomes, Algorithmically determined telephone interview with a nurse
- Medical subject headings
- Vulvar Neoplasms, Vulvar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of circulating tumor-DNADiagnostic test
Liquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA.
Collection of patient-reported outcomesOther
Patient-reported outcomes will be collected at baseline and prospectively during follow-up.
Algorithmically determined telephone interview with a nurseOther
Dependent on the patient's responses on the patient-reported outcome measures.
| Study group | Role | What they receive |
|---|---|---|
| PROM assessment and ctDNA detection during surveillance | Experimental | All participants (n=295) included in the prospective clinical study Receives: Diagnostic Test: Measurement of circulating tumor-DNA; Other: Collection of patient-reported outcomes; Other: Algorithmically determined telephone interview with a nurse |
| Standard surveillance | No intervention | Historical controls (n=1,000) who will be identified by the Danish Gynecological Cancer Database |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Measured: Two years
Overall survival
Measured: Two years
Secondary outcomes (6)
Symptomatology preceding a recurrence
Measured: Two years
Improved quality-of-life as a result of proactive management of late effects on an individual level
Measured: Two years
Improved survival as a result of proactive management of late effects on group level
Measured: Two years
ctDNA detection at time of diagnosis in relation to disease stage
Measured: Two years
ctDNA detection after end of treatment in relation to residual disease
Measured: Two years
ctDNA detection during surveillance in relation to recurrent disease
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Aug 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulva CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,295 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Danish Cancer Society, Danish Comprehensive Cancer Center, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Pernille T. Jensen, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495554
- Sponsor's protocol ID
- 1-10-72-150-23
- Acronym
- DaVulvaRec
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06495554
- Acronym / sponsor ID
- DaVulvaRec / 1-10-72-150-23
- Conditions
- Vulva Cancer, Vulva Neoplasm, Vulvar Cancer, Vulva Disease, Vulvar Neoplasms, Vulvar Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,295 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Danish Cancer Society, Danish Comprehensive Cancer Center, Copenhagen University Hospital, Rigshospitalet
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROM assessment and ctDNA detection during surveillance | Experimental | Diagnostic Test: Measurement of circulating tumor-DNA, Other: Collection of patient-reported outcomes, Other: Algorithmically determined telephone interview with a nurseAll participants (n=295) included in the prospective clinical study |
| Standard surveillance | No intervention | –Historical controls (n=1,000) who will be identified by the Danish Gynecological Cancer Database |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva
- ≥ 18 years of age
- Able to understand oral and written information in Danish
Key exclusion criteria (1 listed)
- Active treatment for concurrent cancer and/or dissemination of concurrent cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of circulating tumor-DNALiquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA. | Diagnostic test | PROM assessment and ctDNA detection during surveillance |
| Collection of patient-reported outcomesPatient-reported outcomes will be collected at baseline and prospectively during follow-up. | Other | PROM assessment and ctDNA detection during surveillance |
| Algorithmically determined telephone interview with a nurseDependent on the patient's responses on the patient-reported outcome measures. | Other | PROM assessment and ctDNA detection during surveillance |
Primary outcome
Recurrence-free survival
Time frame: Two years
Overall survival
Time frame: Two years
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pernille T. Jensen, Professor principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of circulating tumor-DNA, Collection of patient-reported outcomes and Algorithmically determined telephone interview with a nurse in people with Vulva Cancer and Vulva Neoplasm, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Krog, BSc.med. (20995607 ext. +45, loukrg@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: Two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.