NCT06703944: NB

Risk Model for Metastasis Detection of Neuroblastoma

ENROLLING BY INVITATION Last updated 15 May 2025

What this trial tests

trial testing risk model in diagnosis and prognosis in Neuroblastoma (NB) in 500 participants. Enrolling by invitation.

Timeline

1 December 2024

Primary endpoint
1 July 2025

1 December 2026

Quick facts

Lead sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 December 2024
Primary completion	1 July 2025
Estimated completion	1 December 2026
Sites	3 locations across China

Drugs / interventions tested

• risk model in diagnosis and prognosis

Conditions studied

• Neuroblastoma (NB) — all drugs for Neuroblastoma (NB) →
• Prognosis — all drugs for Prognosis →
• Bone Marrow Metastasis — all drugs for Bone Marrow Metastasis →
• Bone Metastases — all drugs for Bone Metastases →

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Eligibility, any sex, with Neuroblastoma (NB) or Prognosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neuroblastoma (NB) is the most common extracranial solid tumor in children, accounting for about 15% of tumor-related mortality. NB patients in high-risk group are prone to bone marrow and/or bone metastases with low five-year overall survival rate. The artificial intelligence (AI) and deep learning technologies have potential to identifying morphological characteristics of bone marrow cytology in clinical practice. In this study, the investigators construct and evaluate the bone marrow cytology-based AI model for detection and prognosis of NB. The main questions of the study as follows:

The question 1: Dose bone marrow cytology-based AI model work for prediction of bone marrow metastasis in NB? The question 2: Dose bone marrow cytology-based AI model work for prediction of bone metastasis in NB? The question 3: Dose bone marrow cytology-based AI model have potential to assist doctors in making individualized predictions of survival outcome? The investigators will retrospectively obtain the participants with NB between January 2019 and June 2024. The follow-up date ended on June 30, 2024.

The internal cohort including participants from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The independent external cohorts including participants form Children's Hospital, Zhejiang University School of Medicine and Shenzhen Children's Hospital.

The investigators collect the clinical data of enrolled participants at the time of the patients' initial admission to the hospital, prior to receiving treatment. The clinical information including age, gender, primary tumor location, tumor grade, bone marrow metastasis state, bone metastasis state, genetic aberrations (MYCN amplification, Chromosome 1p deletion, Chromosome 11q deletion) and lab variables (peripheral blood cell count, bone marrow cytology indicators, the serum concentration of lactate dehydrogenase, neuron specific enolase).

This study is a non-interventional observational study, there is no risk to the participants and investigators. Participants get these benefits:

1. Early Detection: The model helps in early risk identification and personalize treatment.
2. Convenience: Because the model relies on general lab tests, it is easy to carry out can reduce invasive diagnostic procedures.
3. Cost-Effective: Using existing clinical data from routine tests can make the prediction process more cost-effective.
4. Data-Driven Decisions: The AI model improve diagnostic efficiency and support the medical decision.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interpretative diagnostic model for neuroblastoma metastases using bone marrow cytology.
   Ma J, Yao Q, Fu X, Xia Z, et al · · 2026 · PMID 41947227 · DOI 10.1186/s12967-026-08069-2