Neuroblastoma Biology Study

  • Observational
  • Recruiting
  • NCT01587300
Eligibility Details Visit Clinicaltrials.gov

N2004-05: Neuroblastoma Biology Study

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.

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.

Gender
All

Age Group
99 Years and under

Accepting 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.
  • Cancer
  • Neuroblastoma

At a Glance

National Government IDNCT01587300

IRB#11-0471

Lead SponsorNew Approaches to Neuroblastoma Therapy Consortium

Lead PhysicianAmi Desai

Collaborator(s)N/A

EligibilityAll
99 Years and under
Recruiting