Clinical trial · Observational
Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
NCT00588068CI-TRIAL-00096592recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out the genetic and biochemical makeup of your neuroblastic tumor, which influences its aggressiveness and the suitable therapy. These research studies include surface marker analysis, cytogenetics, cancer genes,genome sequencing, tumor growth-related genes and tumor growth in test tubes. Your blood, marrow, and hematopoietic stem cell samples will also be tested for tumors or leukemia cells, and your serum tested for anti-tumor antibodies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor and Marrow Markers | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Tumor and Marrow Markers
- interventionNames
- Other: Tumor and Marrow Markers
Primary outcomes (1)
- measure
- To study the molecular-genetic makeup and metastasis of neuroblastic tumors.
- timeFrame
- 2 years
- description
- Before surgery a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient
Secondary outcomes (2)
- measure
- To study the correlation of these biologic markers with clinical outcome.
- timeFrame
- 2 years
- description
- Before surgery and a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Neuroblastic tumors diagnosed in accordance with the International Neuroblastoma Staging System OR * Clinically suspected neuroblastic tumors. PK DRAW INCLUSION CRITERIA (FOR PK DRAWS ONLY): PK Draw Inclusion Criteria * Patients who receive naxitamab as part of their standard of care Exclusion Criteria: * None
References
Publications (2)
- DERIVEDFelix CA, Slater DJ, Davenport JW, Yu X, Gregory BD, Li MM, Rappaport EF, Cheung NV. KMT2A-MAML2 rearrangement emerged and regressed during neuroblastoma therapy without leukemia after 12.8-year follow-up. Pediatr Blood Cancer. 2022 Jan;69(1):e29344. doi: 10.1002/pbc.29344. Epub 2021 Sep 22. PMID 34550633
- DERIVEDCheung NK, Zhang J, Lu C, Parker M, Bahrami A, Tickoo SK, Heguy A, Pappo AS, Federico S, Dalton J, Cheung IY, Ding L, Fulton R, Wang J, Chen X, Becksfort J, Wu J, Billups CA, Ellison D, Mardis ER, Wilson RK, Downing JR, Dyer MA; St Jude Children's Research Hospital-Washington University Pediatric Cancer Genome Project. Association of age at diagnosis and genetic mutations in patients with neuroblastoma. JAMA. 2012 Mar 14;307(10):1062-71. doi: 10.1001/jama.2012.228. PMID 22416102