Neuroblastoma Biology Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 31 Days - 99 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01587300
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

New Approaches to Neuroblastoma Therapy Consortium
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Shahab Asgharzadeh, MD
Principal Investigator Affiliation Children's Hospital Los Angeles
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroblastoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700

Site Contact

Araz Marachelian, MD

[email protected]

323-361-5687

Palo Alto, California

Status

Recruiting

Address

Lucille Salter Packer Children's Hospital, Stanford University

Palo Alto, California, 94305

Site Contact

Sheri Spunt, MD

[email protected]

323-361-5687

San Francisco, California

Status

Recruiting

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115

Site Contact

Katherine Matthay, MD

[email protected]

415-476-3831

Children Hospital of Colorado, Aurora, Colorado

Status

Recruiting

Address

Children Hospital of Colorado

Aurora, Colorado, 80045

Site Contact

Margaret Macy, MD

[email protected]

720-777-8856

Atlanta, Georgia

Status

Recruiting

Address

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Atlanta, Georgia, 30322

Site Contact

Kelly Goldsmith, MD

[email protected]

404-785-0853

Chicago, Illinois

Status

Recruiting

Address

University of Chicago, Comer Children's Hospital

Chicago, Illinois, 60637

Site Contact

Ami Desai, MD

[email protected]

773-843-3943

Children's Hospital Boston, Boston, Massachusetts

Status

Recruiting

Address

Children's Hospital Boston

Boston, Massachusetts, 02115

Site Contact

Suzanne Shusterman, MD

[email protected]

617-632-4901

C.S Mott Children's Hospital, Ann Arbor, Michigan

Status

Recruiting

Address

C.S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Site Contact

Rajen Mody, MD

[email protected]

323-361-5687

University of North Carolina, Chapel Hill, North Carolina

Status

Not yet recruiting

Address

University of North Carolina

Chapel Hill, North Carolina, 27599

Site Contact

Patrick Thompson, MD

[email protected]

323-361-5687

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039

Site Contact

Brian Weiss, MD

[email protected]

513-636-9863

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318

Site Contact

Yael Mosse, MD

[email protected]

215-590-0965

Fort Worth, Texas

Status

Recruiting

Address

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104

Site Contact

Meaghan Granger, MD

[email protected]

682-885-2580

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Site Contact

Navin Pinto, MD

[email protected]

206-987-5783

International Sites

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Recruiting

Address

Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Site Contact

Meredith Irwin, MD

[email protected]

416-813-7654

Stay Informed & Connected