Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

Recruiting

• Conditions: Neuroblastoma
• Interventions: Other: Tumor and Marrow Markers

• Registration Number: NCT00588068
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

To collect tumor, marrow specimens prospectively to study the molecular-genetic makeup of individual neuroblastic tumor and its metastasis by blood and marrow, and to correlate these findings with clinical outcome, and to relate the signaling circuitry of neuroblastic tumors to that of embryonic neuroectodermal cells. .

Study Timeline

• Study Start: 2000-09-26
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Tumor and Marrow Markers	Tumor and Marrow Markers

Primary Outcome Measures

Name	Time	Method
To study the molecular-genetic makeup and metastasis of neuroblastic tumors.	2 years	Before surgery a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient

Secondary Outcome Measures

Name	Time	Method
To study the correlation of these biologic markers with clinical outcome.	2 years	Before surgery and a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient
To relate neuroblastic tumor and embryonic neuroectodermal cell circuitry.	2 years	Up to six fetal adrenal samples will be obtained (without patient identifiers) from gestational week 20, when neuroblasts are present and thought to be differentiating within the fetal adrenal gland.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States