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Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

This study is currently recruiting participants.
Verified October 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00588068
First Posted: January 8, 2008
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Southern Illinois University
Spanish National Cancer Center
St. Jude Children's Research Hospital
Washington University School of Medicine
University of Texas
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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: 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


Secondary Outcome Measures:
  • 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

  • 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.


Biospecimen Retention:   Samples With DNA
Tumor, marrow and blood samples

Estimated Enrollment: 1500
Actual Study Start Date: September 26, 2000
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Weill Medical College of Cornell University
Investigators
Principal Investigator: Nai-Kong Cheung, M.D., Ph.D. Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
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
First Submitted: December 24, 2007
First Posted: January 8, 2008
Last Update Posted: October 3, 2017
Last Verified: October 2017

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