Tracking tumor DNA over time in neuroblastoma

A Prospective Observational Study of Serial Circulating Tumor DNA and Molecular Residual Disease Monitoring for Molecular Profiling, Treatment Response Assessment, and Early Relapse Detection in Patients With Neuroblastoma

This project tests whether regular blood tests measuring circulating tumor DNA and molecular residual disease can track disease status and detect relapse earlier in children with neuroblastoma.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07516678 on ClinicalTrials.gov

What this trial studies

This is a prospective observational program that enrolls newly diagnosed and relapsed/refractory neuroblastoma patients and collects serial biospecimens during routine clinical care. Plasma samples are obtained at baseline, during treatment, after surgery when applicable, during post-treatment surveillance, and at suspected relapse or progression, with bone marrow or CSF analyzed in selected cases. Molecular testing uses both tumor-informed personalized MRD assays and fixed-panel approaches to characterize baseline genomic alterations and dynamic ctDNA changes. Results will be correlated with imaging, marrow, serum markers, and clinical outcomes to determine whether ctDNA/MRD improves response assessment, molecular remission evaluation, and relapse surveillance.

Who should consider this trial

Good fit: Children with histologically or clinically confirmed neuroblastoma (newly diagnosed or relapsed/refractory) who can provide serial blood samples and consent to clinical data collection.

Not a fit: Patients unable to provide required blood samples, those with tumors that shed minimal ctDNA, or those without sufficient clinical or tissue data for tumor-informed assays are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could detect relapse or progression earlier and provide a minimally invasive way to monitor treatment response.

How similar studies have performed: Prior observational work in neuroblastoma and other pediatric solid tumors has shown ctDNA can reflect disease burden and signal relapse, though tumor-informed MRD testing is still emerging.

Eligibility criteria

Inclusion Criteria:

* Patients with histologically or clinically confirmed neuroblastoma according to institutional or protocol-defined diagnostic criteria.

Newly diagnosed, relapsed, refractory, or progressive neuroblastoma eligible for serial biospecimen collection during routine clinical care.

Availability of peripheral blood samples for ctDNA/MRD analysis at baseline and/or longitudinal follow-up time points.

Availability of clinical data required for molecular-clinical correlation analyses, including response and outcome assessment.

Availability of tumor tissue and matched control samples for tumor-informed assay development, if applicable and feasible.

Written informed consent from a parent or legal guardian, and assent from the participant when applicable.

Exclusion Criteria:

* Inability to provide protocol-required blood samples for ctDNA/MRD testing. Insufficient clinical information for protocol-defined response or outcome analyses.

Poor-quality or insufficient biospecimens that preclude molecular analysis, when molecular testing is a required component of the study dataset.

Any condition that, in the opinion of the investigator, would make study participation inappropriate.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Yizhuo Zhang, Doctor of Haematology

Conditions: Neuroblastoma, ctDNA, molecular residual disease, neuroblastoma, disease monitoring