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Clinical Trials in China / NCT07516678
Recruiting Observational

Serial ctDNA and Molecular Residual Disease Monitoring in Neuroblastoma

NCT07516678 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Observational
Started
2022-01-01
Last updated
2026-04-08

Condition(s) studied

Neuroblastoma

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Clinical Concordance of Serial ctDNA/MRD Dynamics With Disease Status — From baseline through follow-up, up to 36 months
    Proportion of evaluable patients in whom longitudinal ctDNA/MRD status is concordant with protocol-defined clinical disease status, including treatment response, molecular remission, relapse, or progression.
  • Rate of Baseline ctDNA Detectability — At baseline
    Proportion of enrolled patients with detectable tumor-derived alterations in baseline plasma ctDNA/cfDNA samples.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

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Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC Starting soon
BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression Enrolling by invitation
Maintenance Immunotherapy With Deferred Salvage Radiotherapy After Response to Chemoimmunotherapy in Recurrent Nasopharyngeal Carcinoma Recruiting

Other trials for the same condition

Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma Active, not recruiting
18F-mFBG PET Imaging in the Evaluation of Neuroblastoma Recruiting
Phase I Study of Umbilical Cord Blood Natural Killer (NK) Cell Therapy for Children With High-risk, R/R Neuroblastoma. Recruiting
Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma Starting soon
GSL Synthetase Inhibitor Plus GM-CSF and/ or Immune Checkpoint Inhibitor in Previously Treated High-Risk Neuroblastoma. Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07516678 on ClinicalTrials.gov ↗ ← All trials in China