NeuroblastomaNCT01587300
Neuroblastoma Biology Study
An observational study of Neuroblastoma, run by New Approaches to Neuroblastoma Therapy Consortium at 17 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 31 days to 99 years
- Conditions the study is for
- Neuroblastoma
- How many people
- 1,000 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jul 2011to Dec 2099
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 days to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neuroblastoma patients from various NANT sites.
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria on this study.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States16 sites, 14 recruiting
- Recruiting
C.S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Rajen Mody, MD
- Recruiting
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, 30322
Kelly Goldsmith, MD
- Recruiting
Children Hospital of Colorado
Aurora, Colorado, 80045
Margaret Macy, MD
- Recruiting
Children's Hospital Boston
Boston, Massachusetts, 02115
Suzanne Shusterman, MD
- Completed
University of North Carolina
Chapel Hill, North Carolina, 27599
- Recruiting
University of Chicago, Comer Children's Hospital
Chicago, Illinois, 60637
Ami Desai, MD
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Katherine Somers, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Keri Streby, MD
- Not yet recruiting
University of Texas Southwestern
Dallas, Texas, 75235
Tanya Watt, MD
- Recruiting
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
Chelsee Greer, DO
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Araz Marachelian, MD
- Not yet recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Sara Federico, MD
- Completed
Lucille Salter Packer Children's Hospital, Stanford University
Palo Alto, California, 94305
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
Yael Mosse, MD
- Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Kieuhoa Vo, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Mark Fluchel, MD
Canada1 site, 1 recruiting
- Recruiting
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Daniel Morgenstern, MD
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Neuroblastoma
- Medical subject headings
- Neuroblastoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2099 (estimated)
- Study completionDec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Approaches to Neuroblastoma Therapy Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahab Asgharzadeh, MD, Study chair, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587300
- Sponsor's protocol ID
- N2004-05
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2012
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N2004-05: Neuroblastoma Biology Study
- ClinicalTrials.gov ID
- NCT01587300
- Acronym / sponsor ID
- N2004-05
- Conditions
- Neuroblastoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- New Approaches to Neuroblastoma Therapy ConsortiumUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2099 (estimated)
- Study completion
- Dec 2099 (estimated)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 31 days to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neuroblastoma patients from various NANT sites.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria on this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Related trials for Neuroblastoma
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
RecruitingPhase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
Neuroblastoma
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
Neuroblastoma (NBL), Ewing Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shahab Asgharzadeh, MD study chair
Children's Hospital Los Angeles
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma, run by New Approaches to Neuroblastoma Therapy Consortium at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Araz Marachelian, MD (323-361-5687, amarachelian@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.