Neuroblastoma Biology Study

Neuroblastoma Clinical Trial

Official title:

N2004-05: Neuroblastoma Biology Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01587300
• Other study ID #: N2004-05
• Status: Recruiting
• Start date: July 2011
• Est. completion date: December 2099

Study information

• Verified date: August 2023
• Source: New Approaches to Neuroblastoma Therapy Consortium
• Contact: Araz Marachelian, MD
• Phone: 323-361-5687
• Email: amarachelian[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2099
• Est. primary completion date: December 2099
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Days to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroblastoma

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	C.S Mott Children's Hospital	Ann Arbor	Michigan
United States	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus	Atlanta	Georgia
United States	Children Hospital of Colorado	Aurora	Colorado
United States	Children's Hospital Boston	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Chicago, Comer Children's Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Lucille Salter Packer Children's Hospital, Stanford University	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
New Approaches to Neuroblastoma Therapy Consortium

Countries where clinical trial is conducted

United States,  Canada,