Serial ctDNA and Molecular Residual Disease Monitoring in Neuroblastoma

Sponsor
Sun Yat-sen University
Study ID
NCT07516678
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 8, 2026
Start date
Jan 1, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Newly Diagnosed Neuroblastoma Cohort
    Patients with newly diagnosed neuroblastoma undergoing protocol-defined serial ctDNA/MRD monitoring during treatment and follow-up.
  • Arm: Relapsed or Refractory Neuroblastoma Cohort
    Patients with relapsed, refractory, or progressive neuroblastoma undergoing serial ctDNA/MRD monitoring during salvage treatment and follow-up.
  • Arm: Adult Neuroblastoma Cohort
    Adult patients with neuroblastoma undergoing serial ctDNA/MRD monitoring for molecular characterization and disease surveillance.

Primary Outcome Measure

Clinical Concordance of Serial ctDNA/MRD Dynamics With Disease Status [ Time Frame: From baseline through follow-up, up to 36 months ]

Central Contacts

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