Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495554
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Brief Title:
Danish Vulva Cancer Recurrence Study
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DaVulvaRec
Brief 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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None