NeuroblastomaNCT07516678
Serial ctDNA and Molecular Residual Disease Monitoring in Neuroblastoma
An observational study of Neuroblastoma, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroblastoma
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510080
Yizhuo Zhang Professor, Chief Physician, Doctor, zhangyzh@sysucc.org.cn
About this study
Official title: A Prospective Observational Study of Serial Circulating Tumor DNA and Molecular Residual Disease Monitoring for Molecular Profiling, Treatment Response Assessment, and Early Relapse Detection in Patients With Neuroblastoma
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.
Read the detailed description
Neuroblastoma is a biologically and clinically heterogeneous pediatric malignancy. Despite multimodal therapy, a substantial proportion of patients, particularly those with high-risk disease, experience relapse or treatment resistance. Current disease assessment relies on imaging, bone marrow evaluation, serum markers, and tissue-based molecular testing, but these methods may not adequately reflect real-time tumor dynamics, molecular evolution, or minimal residual disease.
Circulating tumor DNA (ctDNA) analysis provides a minimally invasive approach for serial molecular profiling and disease monitoring. In neuroblastoma, ctDNA and molecular residual disease (MRD) testing may help identify baseline genomic alterations, evaluate treatment response, detect persistent molecular disease after surgery or systemic therapy, and provide earlier warning of relapse or progression than conventional clinical assessment in selected patients.
This study prospectively enrolls patients with neuroblastoma, including newly diagnosed and relapsed/refractory cases, and collects serial biospecimens during routine clinical care. Plasma samples are obtained at predefined time points including baseline, during treatment, after surgery when applicable, during post-treatment surveillance, and at suspected relapse or progression. In selected patients, bone marrow and/or cerebrospinal fluid specimens may also be analyzed according to disease status and sample availability. Molecular testing includes tumor-informed personalized MRD assays and/or fixed-panel liquid biopsy assays according to protocol-defined sample availability and assay feasibility.
The study evaluates baseline molecular profiling, ctDNA detectability, dynamic ctDNA/MRD changes during therapy, concordance with clinical response, molecular clearance, and early molecular detection of relapse or progression. Additional analyses include associations between baseline ctDNA metrics and disease stage, risk classification, metastatic status, and other clinicopathologic variables, as well as comparison of the clinical consistency of personalized MRD assays versus fixed-panel approaches.
- Conditions
- Neuroblastoma
- Keywords
- ctDNA, molecular residual disease, neuroblastoma, disease monitoring
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed Neuroblastoma Cohort | Patients with newly diagnosed neuroblastoma undergoing protocol-defined serial ctDNA/MRD monitoring during treatment and follow-up. | |
| Relapsed or Refractory Neuroblastoma Cohort | Patients with relapsed, refractory, or progressive neuroblastoma undergoing serial ctDNA/MRD monitoring during salvage treatment and follow-up. | |
| Adult Neuroblastoma Cohort | Adult patients with neuroblastoma undergoing serial ctDNA/MRD monitoring for molecular characterization and disease surveillance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Concordance of Serial ctDNA/MRD Dynamics With Disease Status
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.
Measured: From baseline through follow-up, up to 36 months
Rate of Baseline ctDNA Detectability
Proportion of enrolled patients with detectable tumor-derived alterations in baseline plasma ctDNA/cfDNA samples.
Measured: At baseline
Secondary outcomes (2)
Comparison of Clinical Concordance Between Personalized MRD Assays and Fixed-Panel Assays
Comparison of the proportion of patients with ctDNA/MRD dynamics concordant with clinical disease status between tumor-informed personalized MRD assays and fixed-panel liquid biopsy assays.
Measured: From baseline through follow-up, up to 36 months
Association Between ctDNA/MRD Clearance and Best Clinical Response
Association between ctDNA/MRD clearance during treatment and best clinical response, including complete response and partial response, as defined by protocol-specified clinical assessment.
Measured: From baseline through end of treatment, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516678
- Sponsor's protocol ID
- NB-ctDNA-2024-01
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Serial Circulating Tumor DNA and Molecular Residual Disease Monitoring for Molecular Profiling, Treatment Response Assessment, and Early Relapse Detection in Patients With Neuroblastoma
- ClinicalTrials.gov ID
- NCT07516678
- Acronym / sponsor ID
- NB-ctDNA-2024-01
- Conditions
- Neuroblastoma
- Keywords
- ctDNA, molecular residual disease, neuroblastoma, disease monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neuroblastoma is a biologically and clinically heterogeneous pediatric malignancy. Despite multimodal therapy, a substantial proportion of patients, particularly those with high-risk disease, experience relapse or treatment resistance. Current disease assessment relies on imaging, bone marrow evaluation, serum markers, and tissue-based molecular testing, but these methods may not adequately reflect real-time tumor dynamics, molecular evolution, or minimal residual disease.
Circulating tumor DNA (ctDNA) analysis provides a minimally invasive approach for serial molecular profiling and disease monitoring. In neuroblastoma, ctDNA and molecular residual disease (MRD) testing may help identify baseline genomic alterations, evaluate treatment response, detect persistent molecular disease after surgery or systemic therapy, and provide earlier warning of relapse or progression than conventional clinical assessment in selected patients.
This study prospectively enrolls patients with neuroblastoma, including newly diagnosed and relapsed/refractory cases, and collects serial biospecimens during routine clinical care. Plasma samples are obtained at predefined time points including baseline, during treatment, after surgery when applicable, during post-treatment surveillance, and at suspected relapse or progression. In selected patients, bone marrow and/or cerebrospinal fluid specimens may also be analyzed according to disease status and sample availability. Molecular testing includes tumor-informed personalized MRD assays and/or fixed-panel liquid biopsy assays according to protocol-defined sample availability and assay feasibility.
The study evaluates baseline molecular profiling, ctDNA detectability, dynamic ctDNA/MRD changes during therapy, concordance with clinical response, molecular clearance, and early molecular detection of relapse or progression. Additional analyses include associations between baseline ctDNA metrics and disease stage, risk classification, metastatic status, and other clinicopathologic variables, as well as comparison of the clinical consistency of personalized MRD assays versus fixed-panel approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed Neuroblastoma Cohort | – | –Patients with newly diagnosed neuroblastoma undergoing protocol-defined serial ctDNA/MRD monitoring during treatment and follow-up. |
| Relapsed or Refractory Neuroblastoma Cohort | – | –Patients with relapsed, refractory, or progressive neuroblastoma undergoing serial ctDNA/MRD monitoring during salvage treatment and follow-up. |
| Adult Neuroblastoma Cohort | – | –Adult patients with neuroblastoma undergoing serial ctDNA/MRD monitoring for molecular characterization and disease surveillance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Concordance of Serial ctDNA/MRD Dynamics With Disease Status
Time frame: 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
Time frame: At baseline
Proportion of enrolled patients with detectable tumor-derived alterations in baseline plasma ctDNA/cfDNA samples.
2 secondary outcomes
Comparison of Clinical Concordance Between Personalized MRD Assays and Fixed-Panel Assays
Time frame: From baseline through follow-up, up to 36 months
Association Between ctDNA/MRD Clearance and Best Clinical Response
Time frame: From baseline through end of treatment, up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhuo Zhang, Doctor of Haematology (+86 18819241079, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Concordance of Serial ctDNA/MRD Dynamics With Disease Status (time frame: From baseline through follow-up, up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.