Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

This study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, March 2009

First Received: December 24, 2007 Last Updated: March 3, 2009 History of Changes

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Southern Illinois University Spanish National Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00588068

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, 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

MedlinePlus related topics: Cancer Neuroblastoma

U.S. FDA Resources

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

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 ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Tumor, marrow and blood samples

Estimated Enrollment:	800
Study Start Date:	September 2000
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (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.

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.

Clinically suspected neuroblastic tumors prior to diagnostic surgery.

Exclusion Criteria:

None

Contacts and Locations

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

Contacts

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

cheungn@mskcc.org

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

Investigators

Principal Investigator:

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

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Nai-Kong Cheung, M.D., Ph.D. )
Study ID Numbers:	00-109
Study First Received:	December 24, 2007
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00588068 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Adrenal Gland
No stage requirement

Study placed in the following topic categories:

Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Epinephrine
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009