Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 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: February 25, 2016
Last verified: February 2016

December 24, 2007
February 25, 2016
September 2000
September 2016   (final data collection date for primary outcome measure)
To study the molecular-genetic makeup and metastasis of neuroblastic tumors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Before surgery a maximum of 5 blood drawings (20-30 ml) will be performed per year (at least one month apart) per patient
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 ]
Complete list of historical versions of study NCT00588068 on ClinicalTrials.gov Archive Site
  • To study the correlation of these biologic markers with clinical outcome. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
To study the correlation of these biologic markers with clinical outcome. [ Time Frame: Before surgery and max 10 times ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
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.
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. .
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Tumor, marrow and blood samples
Non-Probability Sample
Patients will be offered participation in this study by their attending oncologist in the Department of Pediatrics at Memorial Sloan Kettering Cancer Center.
Neuroblastoma
Other: Tumor and Marrow Markers
Tumor and Marrow Markers
1
Tumor and Marrow Markers
Intervention: Other: Tumor and Marrow Markers
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
September 2016
September 2016   (final data collection date for primary outcome measure)

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:

Both
Child, Adult, Senior
No
Contact: Nai-Kong Cheung, M.D., Ph.D. 646-888-2313
Contact: Shakeel Modak, MD 212-639-7623
United States
 
NCT00588068
00-109
No
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
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
Principal Investigator: Nai-Kong Cheung, M.D., Ph.D. Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP