Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

Neuroblastoma Clinical Trial

Official title:

Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00588068
• Other study ID #: 00-109
• Status: Recruiting
• Start date: September 26, 2000
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Nai-Kong Cheung, M.D., Ph.D.
• Phone: 646-888-2313
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Other:
• Tumor and Marrow Markers
Tumor and Marrow Markers

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (7)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the molecular-genetic makeup and metastasis of neuroblastic tumors.	Before surgery a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient	2 years
Secondary	To study the correlation of these biologic markers with clinical outcome.	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 years
Secondary	To relate neuroblastic tumor and embryonic neuroectodermal cell circuitry.	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center website