Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease - A Prospective Observational Clinical Study - A Part of the POB-project
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Association between longitudinal ctDNA status and clinical outcomes after local ablative treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic spread from histopathological diagnosed solid cancer
- •Planned for LAT (local ablative therapy) for OMD (oligometastatic disease)
- •≥ 18 years
- •Written and oral consent
排除标准
- •Other cancer disease within 5 years
- •Conditions that will contraindicate blood samples
结局指标
主要结局
Association between longitudinal ctDNA status and clinical outcomes after local ablative treatment
时间窗: During follow-up up to 5 years
Presence and dynamics of circulating tumor DNA (ctDNA) assessed before LAT, after LAT, and during follow-up, and their association with clinically relevant outcomes including radiologically confirmed recurrence or progression, survival status, and lead time to recurrence.
次要结局
- Detection rate of ctDNA prior to local ablative treatment(Baseline (pre-LAT))
- Correlation between ctDNA and pathological response(During follow-up up to 5 years)
- Elimination patterns of ctDNA following local ablative treatment(During follow-up up to 5 years)
- Correlation between ctDNA and risk of recurrence or early progression(Up to 5 years)
- Correlation between ctDNA and disease-free survival or progression-free survival(Up to 5 years)
- Correlation between ctDNA and overall survival(Up to 5 years)
- Rate of ctDNA-detected minimal residual disease(up to 5 years)
- Lead time between ctDNA detection and imaging-confirmed recurrence or progression(During follow-up up to 5 years)
- Exploratory analysis of total circulating free DNA(Up to 5 years)
研究者
Louise Bach Callesen
Principal Investigator
Aarhus University Hospital