Clinical Utility of ctDNA in the Treatment of Oligometastatic 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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Oligometastatic Cancer. Базовые параметры: от 18 лет · Все.
- 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease - A Prospective Observational Clinical Study - A Part of the POB-project
Обзор
This prospective observational study investigates the clinical utility of circulating tumor DNA (ctDNA) in patients with oligometastatic disease (OMD) undergoing definitive-intent local ablative treatment (LAT). The study aims to evaluate ctDNA as a prognostic and response biomarker before, during, and after LAT across cancer types and treatment modalities. Serial plasma samples and archival tumor tissue will be analyzed to assess ctDNA detection rates, elimination patterns, minimal residual disease, and association with recurrence, progression, and survival outcomes.
Подробное описание
Oligometastatic disease (OMD) represents an intermediate disease state between localized and polymetastatic cancer and may be amenable to curative or long-term disease-controlling local ablative treatment (LAT). Despite careful patient selection, recurrence rates after LAT remain substantial, highlighting the need for improved biological markers to guide treatment decisions and follow-up.
Circulating tumor DNA (ctDNA) is a promising biomarker for prognostication, response assessment, and early detection of recurrence. Pilot studies and systematic reviews conducted by the study group indicate that ctDNA dynamics before and after LAT are associated with treatment outcomes. However, important knowledge gaps remain regarding ctDNA detection rates, elimination patterns, optimal sampling time points, and clinical relevance across metastatic sites, treatment modalities, and oligometastatic states.
This prospective observational study, conducted as part of the Pan-Cancer Oligometastatic Biology (POB) project, will enroll patients with oligometastatic solid tumors planned for definitive-intent LAT. Serial blood samples will be collected before treatment, during treatment when applicable, and throughout follow-up. ctDNA and total circulating free DNA will be analyzed using sensitive molecular techniques. Archival tumor tissue will be retrieved for tumor-informed analyses.
The study will evaluate ctDNA detection rates, elimination patterns, minimal residual disease, lead time to radiological recurrence, and associations with disease-free survival, progression-free survival, and overall survival. Exploratory analyses of immune-related biomarkers will also be performed. The results are expected to support improved biological stratification and monitoring strategies in oligometastatic disease.
Первичные конечные точки
- Association between longitudinal ctDNA status and clinical outcomes after local ablative treatment [Срок оценки: During follow-up up to 5 years]
Вторичные конечные точки (9)
- Detection rate of ctDNA prior to local ablative treatment [Срок оценки: Baseline (pre-LAT)]
- Elimination patterns of ctDNA following local ablative treatment [Срок оценки: During follow-up up to 5 years]
- Correlation between ctDNA and pathological response [Срок оценки: During follow-up up to 5 years]
- Correlation between ctDNA and risk of recurrence or early progression [Срок оценки: Up to 5 years]
- Correlation between ctDNA and disease-free survival or progression-free survival [Срок оценки: Up to 5 years]
- Correlation between ctDNA and overall survival [Срок оценки: Up to 5 years]
- Rate of ctDNA-detected minimal residual disease [Срок оценки: up to 5 years]
- Lead time between ctDNA detection and imaging-confirmed recurrence or progression [Срок оценки: During follow-up up to 5 years]
- Exploratory analysis of total circulating free DNA [Срок оценки: Up to 5 years]
Критерии участия
Критерии включения
- Metastatic spread from histopathological diagnosed solid cancer
- Planned for LAT (local ablative therapy) for OMD (oligometastatic disease)
- ≥ 18 years
- Written and oral consent
Критерии исключения
- Other cancer disease within 5 years
- Conditions that will contraindicate blood samples
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Дания · 1 центр
- Department of Oncology, Aarhus University Hospital — Aarhus N
Идентификаторы
NCT: NCT07426250 · 1-10- 72-122-25