Oligometastatic CancerNCT07426250
Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease
An observational study of Oligometastatic Cancer, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Cancer
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Mar 2026to 1 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with verified oligometastatic cancer disease who are planned for local ablative therapy.
Who may be able to join
- Metastatic spread from histopathological diagnosed solid cancer
- Planned for LAT (local ablative therapy) for OMD (oligometastatic disease)
- ≥ 18 years
- Written and oral consent
Who cannot join
- Other cancer disease within 5 years
- Conditions that will contraindicate blood samples
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology, Aarhus University Hospital
Aarhus N, 8200
Louise B Callesen, MD, PhD, 30482884, Louicall@rm.dk
Louise B Callesen, MD, PhD
About this study
Official title: Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease - A Prospective Observational Clinical Study - A Part of the POB-project
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.
Read the 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.
- Conditions
- Oligometastatic Cancer
- Keywords
- Local Ablative Treatment of Oligometastatic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During follow-up up to 5 years
Secondary outcomes (9)
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
Measured: Baseline (pre-LAT)
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
Measured: During follow-up up to 5 years
Correlation between ctDNA and pathological response
ctDNA status and ctDNA changes will be correlated with pathological response
Measured: During follow-up up to 5 years
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
Measured: Up to 5 years
Correlation between ctDNA and disease-free survival or progression-free survival
Disease-free survival or progression-free survival will be analyzed according to ctDNA status at baseline, post-treatment, and during follow-up to assess the prognostic value of ctDNA in patients treated with definitive-intent local ablative treatment
Measured: Up to 5 years
Correlation between ctDNA and overall survival
Overall survival will be analyzed according to ctDNA status at baseline, post-treatment, and during follow-up to assess the prognostic value of ctDNA in patients treated with definitive-intent local ablative treatment
Measured: Up to 5 years
Rate of ctDNA-detected minimal residual disease
The proportion of patients with detectable ctDNA following completion of definitive-intent local ablative treatment, consistent with molecular minimal residual disease, will be determined and analyzed in relation to clinical outcomes
Measured: up to 5 years
Lead time between ctDNA detection and imaging-confirmed recurrence or progression
The time interval between first detection of ctDNA during follow-up and subsequent radiological confirmation of recurrence or progression will be calculated to estimate the potential lead time provided by ctDNA monitoring
Measured: During follow-up up to 5 years
Exploratory analysis of total circulating free DNA
Total circulating free DNA levels will be quantified and analyzed exploratorily in relation to treatment, ctDNA status, imaging findings, and clinical outcomes to assess potential additional biological or prognostic value
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start17 Mar 2026
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Bach Callesen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426250
- Sponsor's protocol ID
- 1-10- 72-122-25
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease - A Prospective Observational Clinical Study - A Part of the POB-project
- ClinicalTrials.gov ID
- NCT07426250
- Acronym / sponsor ID
- 1-10- 72-122-25
- Conditions
- Oligometastatic Cancer
- Keywords
- Local Ablative Treatment of Oligometastatic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with verified oligometastatic cancer disease who are planned for local ablative therapy.
Key inclusion criteria (4 listed)
- Metastatic spread from histopathological diagnosed solid cancer
- Planned for LAT (local ablative therapy) for OMD (oligometastatic disease)
- ≥ 18 years
- Written and oral consent
Key exclusion criteria (2 listed)
- Other cancer disease within 5 years
- Conditions that will contraindicate blood samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between longitudinal ctDNA status and clinical outcomes after local ablative treatment
Time frame: 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligometastatic Cancer, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise B Callesen, MD, PhD (30482884, Louicall@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between longitudinal ctDNA status and clinical outcomes after local ablative treatment (time frame: During follow-up up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.