Neuroblastoma Biology Study
- Conditions
- Neuroblastoma
- Registration Number
- NCT01587300
- Lead Sponsor
- New Approaches to Neuroblastoma Therapy Consortium
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- There are no exclusion criteria on this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
🇺🇸Atlanta, Georgia, United States
University of Chicago, Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Lucille Salter Packer Children's Hospital, Stanford University
🇺🇸Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Children Hospital of Colorado
🇺🇸Aurora, Colorado, United States
C.S Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States