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Trial Title:
Danish Vulva Cancer Recurrence Study
NCT ID:
NCT06495554
Condition:
Vulva Cancer
Vulva Neoplasm
Vulvar Cancer
Vulva Disease
Vulvar Neoplasms
Vulvar Diseases
PROM
Circulating Tumor DNA
Survivorship
Conditions: Official terms:
Neoplasms
Vulvar Neoplasms
Vulvar Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Measurement of circulating tumor-DNA
Description:
Liquid biopsies will be collected at baseline and prospectively during follow-up to
measure circulating tumor-DNA.
Arm group label:
PROM assessment and ctDNA detection during surveillance
Intervention type:
Other
Intervention name:
Collection of patient-reported outcomes
Description:
Patient-reported outcomes will be collected at baseline and prospectively during
follow-up.
Arm group label:
PROM assessment and ctDNA detection during surveillance
Intervention type:
Other
Intervention name:
Algorithmically determined telephone interview with a nurse
Description:
Dependent on the patient's responses on the patient-reported outcome measures.
Arm group label:
PROM assessment and ctDNA detection during surveillance
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. 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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aarhus University Hospital
Address:
City:
Aarhus N
Zip:
8200
Country:
Denmark
Contact:
Last name:
Louise Krog, BSc.med.
Phone:
+4520995607
Email:
loukrg@rm.dk
Start date:
August 15, 2024
Completion date:
December 31, 2032
Lead sponsor:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Collaborator:
Agency:
Danish Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Source:
University of Aarhus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06495554
