Serial ctDNA and Molecular Residual Disease Monitoring in Neuroblastoma

Summary

This prospective observational study evaluates serial circulating tumor DNA (ctDNA) and molecular residual disease (MRD) monitoring in patients with neuroblastoma. The study aims to characterize baseline genomic alterations, assess ctDNA detectability and dynamic changes during treatment and follow-up, compare tumor-informed personalized MRD assays with fixed-panel assays, and determine the clinical utility of ctDNA/MRD for treatment response assessment, molecular remission evaluation, relapse surveillance, and early detection of disease progression.

Eligibility

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.

Conditions2

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