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Neuroblastoma Biology Study

Sponsor
New Approaches to Neuroblastoma Therapy Consortium (Other)
Overall Status
Recruiting
CT.gov ID
NCT01587300
Collaborator
(none)
1,000
Enrollment
14
Locations
155
Duration (Months)
71.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Medical scientists want to find better ways to treat neuroblastoma and to find ways to prevent the tumor from growing back. To do this, they need more information about the characteristics of neuroblastoma cells. Therefore, they want to study samples of neuroblastoma tissues and neuroblastoma and normal cells in the blood and bone marrow that may be related to the growth of neuroblastoma cells. Doctors and other medical scientists also want to find better ways to detect and measure neuroblastoma to improve the ability to follow the response of tumor cells to therapy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purposes of this study are:

    To establish a storage place or bank of samples of blood, bone marrow, and/or tumor, and molecular components isolated from these samples from children with neuroblastoma. The stored specimens will be shared with laboratory researchers studying high risk neuroblastoma.

    To evaluate a new test of blood and bone marrow specimens to find tumor cells. The results of this new test, called 5-gene TaqMan® Low Density Array or TLDA, will be compared between blood and bone marrow and imaging (radiology) studies. Radiology studies (CT scans, MRI scans, and MIBG scans) and the TLDA test will be compared for their ability to measure the amount of tumor present and how this changes with therapy.

    To collect clinical data (such as treatments received, date of diagnosis, tumor stage, etc) and radiology scans to provide this information as needed for the laboratory studies to be done on the specimens.

    To obtain neuroblastoma tumor cells from tumor tissue, bone marrow, and/or blood to use to start cell lines, or tumor cells that will keep growing in the laboratory. These cell lines will be shared with laboratory researchers studying high risk neuroblastoma.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    N2004-05: Neuroblastoma Biology Study
    Study Start Date :
    Jul 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      31 Days to 99 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Patients must be greater than or 31 days of age.

      • Patients must have had a diagnosis of high risk neuroblastoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.

      • All patients with refractory or recurrent high risk neuroblastoma at NANT institutions are eligible regardless of disease status (including no measurable or evaluable tumor) as long as they undergo a disease evaluation and appropriate samples are submitted.

      • Additionally, all patients with high risk neuroblastoma without relapse treated at a NANT institution are eligible if undergoing a disease evaluation, as long as Children's Oncology Group specimens are prioritized.

      Exclusion Criteria:
      • There are no exclusion criteria on this study.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Children's Hospital Los Angeles Los Angeles California United States 90027-0700
      2 Lucille Salter Packer Children's Hospital, Stanford University Palo Alto California United States 94305
      3 UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California United States 94115
      4 Children Hospital of Colorado Aurora Colorado United States 80045
      5 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta Georgia United States 30322
      6 University of Chicago, Comer Children's Hospital Chicago Illinois United States 60637
      7 Children's Hospital Boston Boston Massachusetts United States 02115
      8 C.S Mott Children's Hospital Ann Arbor Michigan United States 48109
      9 University of North Carolina Chapel Hill North Carolina United States 27599
      10 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229-3039
      11 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104-4318
      12 Cook Children's Medical Center - Fort Worth Fort Worth Texas United States 76104
      13 Seattle Children's Hospital Seattle Washington United States 98105
      14 Hospital for Sick Children Toronto Ontario Canada M5G 1X8

      Sponsors and Collaborators

      • New Approaches to Neuroblastoma Therapy Consortium

      Investigators

      • Study Chair: Shahab Asgharzadeh, MD, Children's Hospital Los Angeles

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      New Approaches to Neuroblastoma Therapy Consortium
      ClinicalTrials.gov Identifier:
      NCT01587300
      Other Study ID Numbers:
      • N2004-05
      First Posted:
      Apr 30, 2012
      Last Update Posted:
      May 20, 2022
      Last Verified:
      May 1, 2022
      Additional relevant MeSH terms:
      Neuroblastoma

      Study Results

      No Results Posted as of May 20, 2022