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Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome

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.
 
ClinicalTrials.gov Identifier: NCT00588068
Recruitment Status : Recruiting
First Posted : January 8, 2008
Last Update Posted : March 13, 2020
Sponsor:
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

Tracking Information
First Submitted Date December 24, 2007
First Posted Date January 8, 2008
Last Update Posted Date March 13, 2020
Actual Study Start Date September 26, 2000
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2015)
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
Original Primary Outcome Measures
 (submitted: January 7, 2008)
To study the molecular-genetic makeup and metastasis of neuroblastic tumors. [ Time Frame: Before surgery and a maximum of 10 times ]
Change History
Current Secondary Outcome Measures
 (submitted: September 25, 2015)
  • 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.
Original Secondary Outcome Measures
 (submitted: January 7, 2008)
To study the correlation of these biologic markers with clinical outcome. [ Time Frame: Before surgery and max 10 times ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
Official Title Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
Brief Summary 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.
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. .
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor, marrow and blood samples
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.
Condition Neuroblastoma
Intervention Other: Tumor and Marrow Markers
Tumor and Marrow Markers
Study Groups/Cohorts 1
Tumor and Marrow Markers
Intervention: Other: Tumor and Marrow Markers
Publications * 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.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 15, 2012)
1500
Original Estimated Enrollment
 (submitted: January 7, 2008)
600
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Neuroblastic tumors diagnosed in accordance with the International Neuroblastoma Staging System

OR

  • Clinically suspected neuroblastic tumors.

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Nai-Kong Cheung, M.D., Ph.D. 646-888-2313
Contact: Shakeel Modak, MD 212-639-7623
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00588068
Other Study ID Numbers 00-109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study 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
  • Weill Medical College of Cornell University
Investigators
Principal Investigator: Nai-Kong Cheung, M.D., Ph.D. Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2020