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NCT Number: NCT00588068

Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

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.

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Key information

Conditions

Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Nai-Kong Cheung, M.D., Ph.D.

CONTACT

Nai-Kong Cheung, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor and Marrow Markers

Other

Tumor and Marrow Markers

Primary outcomes

  1. To study the molecular-genetic makeup and metastasis of neuroblastic tumors.

    Time frame: 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 outcomes

  1. To study the correlation of these biologic markers with clinical outcome.

    Time frame: 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

  2. To relate neuroblastic tumor and embryonic neuroectodermal cell circuitry.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nai-Kong Cheung, M.D., Ph.D.

CONTACT

646-888-2313

Shakeel Modak, MD

CONTACT

212-639-7623

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Southern Illinois University
  • Spanish National Cancer Center
  • St. Jude Children's Research Hospital
  • University of Texas
  • Washington University School of Medicine
  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
2000
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2008
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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