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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Danish Cancer Society | OTHER |
| Danish Comprehensive Cancer Center | OTHER |
| Rigshospitalet, Denmark |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROM assessment and ctDNA detection during surveillance | Experimental | All 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of circulating tumor-DNA | Diagnostic Test | Liquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | Two years | |
| Overall survival | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatology preceding a recurrence | Two years | |
| Improved quality-of-life as a result of proactive management of late effects on an individual level | Two years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise Krog, BSc.med. | Contact | 20995607 | +45 | loukrg@rm.dk |
| Pernille T. Jensen, Professor | Contact | 20952061 | +45 | petije@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Pernille T. Jensen, Professor | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
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| OTHER |
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| Collection of patient-reported outcomes | Other | Patient-reported outcomes will be collected at baseline and prospectively during follow-up. |
|
| Algorithmically determined telephone interview with a nurse | Other | Dependent on the patient's responses on the patient-reported outcome measures. |
|
| Improved survival as a result of proactive management of late effects on group level |
| Two years |
| ctDNA detection at time of diagnosis in relation to disease stage | Two years |
| ctDNA detection after end of treatment in relation to residual disease | Two years |
| ctDNA detection during surveillance in relation to recurrent disease | Two years |
| Copenhagen University Hospital | Recruiting | Copenhagen | 2100 | Denmark |
|
| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| D014845 | Vulvar Diseases |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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