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NCT Number: NCT07426250

Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease

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.

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Key information

Conditions

Oligometastatic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location contact

Karen-Lise G Spindler, Professor, MD, PhD

PRINCIPAL_INVESTIGATOR

Louise B Callesen, MD, PhD

CONTACT

[email protected]

30482884

Louise B Callesen, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Detection rate of ctDNA prior to local ablative treatment

    Time frame: Baseline (pre-LAT)

    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

  2. Elimination patterns of ctDNA following local ablative treatment

    Time frame: During follow-up up to 5 years

    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

  3. Correlation between ctDNA and pathological response

    Time frame: During follow-up up to 5 years

    ctDNA status and ctDNA changes will be correlated with pathological response

  4. Correlation between ctDNA and risk of recurrence or early progression

    Time frame: Up to 5 years

    The association between ctDNA and the subsequent risk of recurrence or early disease progression will be evaluated

  5. Correlation between ctDNA and disease-free survival or progression-free survival

    Time frame: Up to 5 years

    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

  6. Correlation between ctDNA and overall survival

    Time frame: Up to 5 years

    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

  7. Rate of ctDNA-detected minimal residual disease

    Time frame: up to 5 years

    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

  8. Lead time between ctDNA detection and imaging-confirmed recurrence or progression

    Time frame: During follow-up up to 5 years

    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

  9. Exploratory analysis of total circulating free DNA

    Time frame: Up to 5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Karen-Lise G Spindler, Professor, MD, PhD

CONTACT

[email protected]

91167244

Louise B Callesen, MD, PhD

CONTACT

[email protected]

30482884

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease - A Prospective Observational Clinical Study - A Part of the POB-project

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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