Serial ctDNA and Molecular Residual Disease Monitoring in Neuroblastoma (NCT07516678) | Clinical Trial Compass
RecruitingNot Applicable
Serial ctDNA and Molecular Residual Disease Monitoring in Neuroblastoma
China200 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Concordance of Serial ctDNA/MRD Dynamics With Disease Status
Timeframe: From baseline through follow-up, up to 36 months