Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

June 29, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nai-Kong Cheung, M.D., Ph.D.
  • Phone Number: 646-888-2313

Study Contact Backup

  • Name: Shakeel Modak, MD
  • Phone Number: 212-639-7623

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Nai-Kong Cheung, M.D., Ph.D.
        • Principal Investigator:
          • Nai-Kong Cheung, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be offered participation in this study by their attending oncologist in the Department of Pediatrics at Memorial Sloan Kettering Cancer Center.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Tumor and Marrow Markers
Other: Tumor and Marrow Markers
Tumor and Marrow Markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

Investigators

  • Principal Investigator: Nai-Kong Cheung, M.D., Ph.D., Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2000

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

December 24, 2007

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimated)

January 8, 2008

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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