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N2004-05: Neuroblastoma Biology Study


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Open (Enrolling)
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Neuroblastoma

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Trial Information

N2004-05: Neuroblastoma Biology Study


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.


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Authority:

United States: Institutional Review Board

Study ID:

N2004-05

NCT ID:

NCT01587300

Start Date:

July 2011

Completion Date:

December 2015

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
Children's Hospital BostonBoston, Massachusetts  02115
Duke University Medical CenterDurham, North Carolina  27710
Lucille Salter Packer Children's Hospital, Stanford UniversityPalo Alto, California  94305
C.S Mott Children's HospitalAnn Arbor, Michigan  48109
University of Chicago, Comer Children's HospitalChicago, Illinois  60637