Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease
ConditionOligometastatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Metastatic spread from histopathological diagnosed solid cancer
Planned for LAT (local ablative therapy) for OMD (oligometastatic disease)
≥ 18 years
Written and oral consent
Disqualifiers
Other cancer disease within 5 years
Conditions that will contraindicate blood samples
Trial population
The study population consists of patients with verified oligometastatic cancer disease who are planned for local ablative therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Association between longitudinal ctDNA status and clinical outcomes after local ablative treatment
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.
Time frame
During follow-up up to 5 yearsSecondary outcomes
1
Detection rate of ctDNA prior to local ablative treatment
The proportion of patients with detectable circulating tumor DNA in plasma prior to initiation of local ablative treatment will be assessed. Detection rates will be evaluated overall and stratified by treatment modality, cancer type and metastatic site
Time frame
Baseline (pre-LAT)2
Elimination patterns of ctDNA following local ablative treatment
Changes in ctDNA levels following local ablative treatment will be analyzed to characterize elimination patterns over time. Changes in ctDNA will be assessed in relation to treatment modality, cancer type, metastatic site, and timing of sampling to evaluate biological response to treatment
Time frame
During follow-up up to 5 years3
Correlation between ctDNA and pathological response
ctDNA status and ctDNA changes will be correlated with pathological response
Time frame
During follow-up up to 5 years4
Correlation between ctDNA and risk of recurrence or early progression
The association between ctDNA and the subsequent risk of recurrence or early disease progression will be evaluated
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov