The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,295
- 试验地点
- 4
- 主要终点
- Recurrence-free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva
- •≥ 18 years of age
- •Able to understand oral and written information in Danish
排除标准
- •Active treatment for concurrent cancer and/or dissemination of concurrent cancer
结局指标
主要结局
Recurrence-free survival
时间窗: Two years
Overall survival
时间窗: Two years
次要结局
- Improved survival as a result of proactive management of late effects on group level(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)
- 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)
- ctDNA detection at time of diagnosis in relation to disease stage(Two years)