Registry of Neuroblastic Tumours with Spinal Canal Involvement
Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)
This study is collecting information on young patients with neuroblastic tumors that affect the spinal canal to see how different factors impact their health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Associazione Italiana Ematologia Oncologia Pediatrica Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Genova) |
| Trial ID | NCT02559804 on ClinicalTrials.gov |
What this trial studies
This observational, multi-centre registry aims to document the natural history of peripheral neuroblastic tumours that present with spinal canal involvement (SCI). It will evaluate the impact of various risk factors on neurological and orthopedic outcomes in affected patients. The study focuses on patients under 18 years old, both symptomatic and asymptomatic, and will collect data over a minimum follow-up period of five years. The findings may help refine treatment guidelines and improve patient management strategies.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years diagnosed with peripheral neuroblastic tumours presenting with spinal canal involvement, regardless of symptom status.
Not a fit: Patients with neuroblastic tumours that do not involve the spinal canal or those who have received chemotherapy in the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols and outcomes for children with neuroblastic tumours presenting with spinal canal involvement.
How similar studies have performed: While there are few publications on this topic, most are retrospective; thus, this prospective approach is novel and may provide valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of peripheral neuroblastic tumour - peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with SCI, symptomatic or asymptomatic, independent of disease extension (stage), and clinical course (first diagnosis or relapse/progression) * No previous chemotherapy, except steroids, in the last 6 months * Age \<18 years * Minimal planned follow-up of 5 years * Parent/patient written informed consent (Appendix 1(A,B,C)) Exclusion Criteria: * Invasion of intervertebral foramina only
Where this trial is running
Genova
- Istituto Giannina Gaslini — Genova, Italy (Recruiting)
Study contacts
- Principal investigator: Riccardo Haupt, MD — Istituto Giannina Gaslini Genova
- Study coordinator: Riccardo Haupt, MD
- Email: riccardohaupt@ospedale-gaslini.ge.it
- Phone: 01056363462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.