Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Southern Illinois University
Spanish National Cancer Center
St. Jude Children's Research Hospital
Washington University School of Medicine
University of Texas
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588068
First received: December 24, 2007
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Neuroblastoma
Other: Tumor and Marrow Markers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To study the molecular-genetic makeup and metastasis of neuroblastic tumors. [ Time Frame: Before surgery and a maximum of 10 times ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the correlation of these biologic markers with clinical outcome. [ Time Frame: Before surgery and max 10 times ] [ Designated as safety issue: No ]
  • To relate neuroblastic tumor and embryonic neuroectodermal cell circuitry. [ Time Frame: Up to three fetal adrenal samples will be obtained (without patient identifiers) at ~ gestational weeks 16, 18, and 20, when neuroblasts are present and thought to be differentiating within the fetal adrenal gland ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumor, marrow and blood samples


Estimated Enrollment: 1500
Study Start Date: September 2000
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Tumor and Marrow Markers
Other: Tumor and Marrow Markers
Tumor and Marrow Markers

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. .

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Neuroblastic tumors diagnosed in accordance with the International Neuroblastoma Staging System viz., either (a) histologic confirmation (by the MSKCC Department of Pathology) which may involve immunohistochemical, ultrastructural, or cytogenetic studies, or (b) elevated urinary catecholamines plus tumor cells/clumps in the bone marrow.

OR

  • Clinically suspected neuroblastic tumors prior to diagnostic surgery.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588068

Contacts
Contact: Nai-Kong Cheung, M.D., Ph.D. 646-888-2313
Contact: Shakeel Modak, MD 212-639-7623

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nai-Kong Cheung, M.D., Ph.D.         
Principal Investigator: Nai-Kong Cheung, M.D., Ph.D.         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Southern Illinois University
Spanish National Cancer Center
St. Jude Children's Research Hospital
Washington University School of Medicine
University of Texas
Investigators
Principal Investigator: Nai-Kong Cheung, M.D., Ph.D. Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided by Memorial Sloan-Kettering Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588068     History of Changes
Other Study ID Numbers: 00-109
Study First Received: December 24, 2007
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Adrenal Gland
No stage requirement

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on September 22, 2014