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Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00588068
Enrollment
2070
Registered
2008-01-08
Start date
2000-09-26
Completion date
2026-09-30
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

Adrenal Gland, No stage requirement

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. .

Interventions

OTHERTumor and Marrow Markers

Tumor and Marrow Markers

Sponsors

Southern Illinois University
CollaboratorOTHER
Spanish National Cancer Center
CollaboratorUNKNOWN
St. Jude Children's Research Hospital
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
University of Texas
CollaboratorOTHER
Weill Medical College of Cornell University
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
To study the correlation of these biologic markers with clinical outcome.2 yearsBefore 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 yearsUp 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.

Countries

United States

Contacts

Primary ContactNai-Kong Cheung, M.D., Ph.D.
646-888-2313
Backup ContactShakeel Modak, MD
212-639-7623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026