Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease

NCT07426250 | Not Yet Recruiting DMC

• 1 other identifier: 1-10- 72-122-25
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Oligometastatic Cancer

Keywords

Local Ablative Treatment of Oligometastatic Disease

Outcome Measures

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.

  During follow-up up to 5 years

Secondary Outcomes (9)

• Detection rate of ctDNA prior to local ablative treatment

  Baseline (pre-LAT)

• Elimination patterns of ctDNA following local ablative treatment

  During follow-up up to 5 years

• Correlation between ctDNA and pathological response

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with verified oligometastatic cancer disease who are planned for local ablative therapy.

You may qualify if:

• Metastatic spread from histopathological diagnosed solid cancer
• Planned for LAT (local ablative therapy) for OMD (oligometastatic disease)
• ≥ 18 years
• Written and oral consent

You may not qualify if:

• Other cancer disease within 5 years
• Conditions that will contraindicate blood samples

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (plasma, serum, whole blood, and buffy coat) and archival formalin-fixed paraffin-embedded (FFPE) tumor tissue will be collected for translational research. Plasma samples will be analyzed for circulating tumor DNA (ctDNA) and total circulating free DNA using sensitive molecular techniques, including ddPCR. Archival tumor tissue will be used for tumor-informed analyses and comparison with plasma-based findings. Residual biological material may be stored in a research biobank for up to 10 years following completion of project-specific analyses, subject to separate informed consent.

Central Study Contacts

Louise B Callesen, MD, PhD

CONTACT

30482884; Louicall@rm.dk

Karen-Lise G Spindler, Professor, MD, PhD

CONTACT

91167244; K.g.spindler@oncology.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

DK (1)