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Neuroblastoma Biology Study

Status
Active
Cancer Type
Neuroblastoma
Trial Phase
Eligibility
31 Days - 99 Years, Male and Female
Study Type
Other
NCT ID
NCT01587300
Protocol IDs
N2004-05 (primary)
Study Sponsor
New Approaches to Neuroblastoma Treatment (NANT)

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.

Objectives

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.

Eligibility

  1. Patients must be greater than or 31 days of age.
  2. 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.
  3. 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.
  4. 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.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.