NCT00588068

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,070

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Sep 2000Sep 2026

Study Start

First participant enrolled

September 26, 2000

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
18.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

25.9 years

First QC Date

December 24, 2007

Last Update Submit

October 13, 2025

Conditions

Neuroblastoma

Keywords

Adrenal GlandNo stage requirement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    2 years

  • To relate neuroblastic tumor and embryonic neuroectodermal cell circuitry.

    2 years

Study Arms (1)

1

Tumor and Marrow Markers

Other: Tumor and Marrow Markers

Interventions

Tumor and Marrow MarkersOTHER

Tumor and Marrow Markers

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Neuroblastic tumors diagnosed in accordance with the International Neuroblastoma Staging System
  • Clinically suspected neuroblastic tumors.
  • Patients who receive naxitamab as part of their standard of care

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Publications (2)

  • Felix CA, Slater DJ, Davenport JW, Yu X, Gregory BD, Li MM, Rappaport EF, Cheung NV. KMT2A-MAML2 rearrangement emerged and regressed during neuroblastoma therapy without leukemia after 12.8-year follow-up. Pediatr Blood Cancer. 2022 Jan;69(1):e29344. doi: 10.1002/pbc.29344. Epub 2021 Sep 22.

    PMID: 34550633DERIVED

  • Cheung NK, Zhang J, Lu C, Parker M, Bahrami A, Tickoo SK, Heguy A, Pappo AS, Federico S, Dalton J, Cheung IY, Ding L, Fulton R, Wang J, Chen X, Becksfort J, Wu J, Billups CA, Ellison D, Mardis ER, Wilson RK, Downing JR, Dyer MA; St Jude Children's Research Hospital-Washington University Pediatric Cancer Genome Project. Association of age at diagnosis and genetic mutations in patients with neuroblastoma. JAMA. 2012 Mar 14;307(10):1062-71. doi: 10.1001/jama.2012.228.

    PMID: 22416102DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Tumor, marrow and blood samples

MeSH Terms

Conditions

Neuroblastoma

Interventions

Tumor Burden

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Body Weights and MeasuresAnthropometryInvestigative Techniques

Study Officials

  • Nai-Kong Cheung, M.D., Ph.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

646-888-2313

Shakeel Modak, MD

CONTACT

212-639-7623

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2007

First Posted

January 8, 2008

Study Start

September 26, 2000

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

October 15, 2025

Record last verified: 2025-10

Locations

US(1)