NCT07516678 Serial ctDNA and Molecular Residual Disease Monitoring in Neuroblastoma
| NCT ID | NCT07516678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Neuroblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07516678 clinical trial?
This trial is open to participants of all sexes, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07516678 currently recruiting?
Yes, NCT07516678 is actively recruiting participants. Contact the research team at zhangyzh@sysucc.org.cn for enrollment information.
Where is the NCT07516678 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07516678 clinical trial?
NCT07516678 is sponsored by Sun Yat-sen University. The trial plans to enroll 200 participants.