Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Oligometastatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease - A Prospective Observational Clinical Study - A Part of the POB-project
Overview
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.
Detailed description
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.
Primary outcome measures
- Association between longitudinal ctDNA status and clinical outcomes after local ablative treatment [Time frame: During follow-up up to 5 years]
Secondary outcome measures (9)
- Detection rate of ctDNA prior to local ablative treatment [Time frame: Baseline (pre-LAT)]
- Elimination patterns of ctDNA following local ablative treatment [Time frame: During follow-up up to 5 years]
- Correlation between ctDNA and pathological response [Time frame: During follow-up up to 5 years]
- Correlation between ctDNA and risk of recurrence or early progression [Time frame: Up to 5 years]
- Correlation between ctDNA and disease-free survival or progression-free survival [Time frame: Up to 5 years]
- Correlation between ctDNA and overall survival [Time frame: Up to 5 years]
- Rate of ctDNA-detected minimal residual disease [Time frame: up to 5 years]
- Lead time between ctDNA detection and imaging-confirmed recurrence or progression [Time frame: During follow-up up to 5 years]
- Exploratory analysis of total circulating free DNA [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Metastatic spread from histopathological diagnosed solid cancer
- Planned for LAT (local ablative therapy) for OMD (oligometastatic disease)
- ≥ 18 years
- Written and oral consent
Exclusion criteria
- Other cancer disease within 5 years
- Conditions that will contraindicate blood samples
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Department of Oncology, Aarhus University Hospital — Aarhus N
Identifiers
NCT: NCT07426250 · 1-10- 72-122-25