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Идёт набор NCT06495554

Danish Vulva Cancer Recurrence Study

Без фазы С лечением Vulva Cancer Vulva Neoplasm Vulvar Cancer Vulva Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Measurement of circulating tumor-DNA, Collection of patient-reported outcomes, Algorithmically determined telephone interview with a nurse.
Кому может быть актуально
Состояния в реестре: Vulva Cancer, Vulva Neoplasm, Vulvar Cancer, Vulva Disease. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Value of Patient-reported Outcome Measure Assessment and Circulating Tumor-DNA to Detect Early Relapse During Surveillance in Women With Vulva Cancer

Обзор

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.

Вмешательства

  • Диагностический тест Measurement of circulating tumor-DNA
    Liquid biopsies will be collected at baseline and prospectively during follow-up to measure circulating tumor-DNA.
  • Другое Collection of patient-reported outcomes
    Patient-reported outcomes will be collected at baseline and prospectively during follow-up.
  • Другое Algorithmically determined telephone interview with a nurse
    Dependent on the patient's responses on the patient-reported outcome measures.

Первичные конечные точки

  • Recurrence-free survival [Срок оценки: Two years]
  • Overall survival [Срок оценки: Two years]
Вторичные конечные точки (6)
  • Symptomatology preceding a recurrence [Срок оценки: Two years]
  • Improved quality-of-life as a result of proactive management of late effects on an individual level [Срок оценки: Two years]
  • Improved survival as a result of proactive management of late effects on group level [Срок оценки: Two years]
  • ctDNA detection at time of diagnosis in relation to disease stage [Срок оценки: Two years]
  • ctDNA detection after end of treatment in relation to residual disease [Срок оценки: Two years]
  • ctDNA detection during surveillance in relation to recurrent disease [Срок оценки: Two years]

Критерии участия

Критерии включения

  • Primary or recurrent biopsy-verified squamous cell carcinoma of the vulva
  • ≥ 18 years of age
  • Able to understand oral and written information in Danish

Критерии исключения

  • Active treatment for concurrent cancer and/or dissemination of concurrent cancer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Дания · 2 центра
  • Aarhus University Hospital — Aarhus N
  • Copenhagen University Hospital — Copenhagen

Идентификаторы

NCT: NCT06495554 · 1-10-72-150-23

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗