Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
This study is currently recruiting participants.
Verified January 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
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: January 3, 2013
Last verified: January 2013
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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 2013 |
| Estimated Primary Completion Date: | September 2013 (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
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: | January 3, 2013 |
| 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 May 16, 2013