Neuroblastoma Precision Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02868268|
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : January 31, 2023
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|Condition or disease||Intervention/treatment|
|Neuroblastoma||Other: Gene panel sequencing of tumor specimens|
|Study Type :||Observational|
|Actual Enrollment :||93 participants|
|Official Title:||N2015-01: Neuroblastoma Precision Trial|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Relapsed/Refractory Neuroblastoma Pts
History of high risk neuroblastoma (NBL) according to Childrens Oncology Group (COG) risk classification with relapsed/progressive, refractory or persistent neuroblastoma. Archival or biopsied tumor specimens are provided for gene panel sequencing to subjects with potentially targetable genetic and/or immunologic biomarkers. A clinical report will be provided to subjects/subject physician detailing observed mutations and identified NBL subgroups and information on clinical trials that best match them. Subjects will be followed and data collected on treatments administered for one year after receiving this clinical report.
Other: Gene panel sequencing of tumor specimens
Archival or biopsied tumor specimens will undergo gene panel sequencing to identify subgroups with targetable genetic (ALK, MAPK pathway, Metabolic-related genes) and/or immunologic (tumor associated macrophage infiltration, PD-L1 expression) biomarkers in neuroblastoma. A clinical report will be provided to subjects/subject physician detailing observed mutations and identified NBL subgroups and information on clinical trials that best match them. Subjects will be followed and data collected on treatments administered for one year after receipt of clinical report.
- Identify genomic alterations, whether targetable alterations are present and within 4 defined NBL subgroups or outside of these 4 defined NBL subgroups. Identify presence/absence of immunologic biomarkers common to NBL. [ Time Frame: 6 weeks ]Archival or biopsied tumor specimens undergo gene panel sequencing and/or immunohistochemistry and a list of all genetic/immunologic alterations are identified. Was an actionable genetic alteration identified and were any of these alterations within 4 NBL specific subgroups (ALK, MAPK, Metabolic, Immune reactive) or outside of the 4 NBL specific subgroups.
- How many subjects are biopsied or provide available tumor that is found to be adequate for gene panel sequencing and produces a clinical report [ Time Frame: 6 weeks ]Identify number of subjects who successfully provide tumor from either a procedure or archival sources and whether this tumor is adequate for analysis (>= 30% tumor present/specimen) as determined locally and centrally. Of these specimens that are found to be adequate and sent to the gene sequencing center, how many result in a clinical report being issued.
- How many patients with bone marrow aspirates performed that contain < 30% tumor cells are able to be enriched and genetic alterations identified [ Time Frame: 1 year ]Identify number of subjects who successfully provide tumor from either a bone marrow aspiration or archival sources and < 30% tumor present. Was tumor enrichment attempted and # of patients where enrichment was attempted and successful to allow gene sequencing and identification of genetic/immunologic alterations. Was an actionable genetic alteration identified and were any of these alterations within 4 NBL specific subgroups (ALK, MAPK, Metabolic, Immune reactive) or outside of the 4 NBL specific subgroups.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||1 Year to 30 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Patients must be ≥ 1 year and ≤ 30 years of age at study registration
- Patients must have had a diagnosis of neuroblastoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
- Patients must have a history of high-risk neuroblastoma according to
- COG risk classification at the time of study registration. Patients must have at least one of the following: Recurrent/progressive disease, Refractory disease, Persistent disease
- Patient must be willing to undergo a clinically indicated biopsy and meet at least one of the following requirements: Bone biopsy, Soft tissue biopsy, Bone marrow biopsy and aspirate
- Patients must not be receiving any other anti-cancer agents or radiotherapy during the interval
- Patients with disease of any major organ system that would compromise their ability to withstand biopsy procedures of soft tissue, bone and/or bone marrow.
- Patients who enroll and successfully receive a NANT Precision Report may not re-enroll at a future time.
- Patient declines participation in NANT 2004-05, the NANT Biology Study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868268
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94143|
|United States, Colorado|
|Children Hospital of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Children's Memorial Hospital - Chicago|
|Chicago, Illinois, United States, 60614|
|United States, Massachusetts|
|Childrens Hospital Boston, Dana-Farber Cancer Institute.|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|C.S Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Texas|
|Cook Children's Healthcare System|
|Fort Worth, Texas, United States, 76104|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Study Chair:||Shahab Asgharzadeh, MD||Children's Hospital Los Angeles|
|Responsible Party:||New Approaches to Neuroblastoma Therapy Consortium|
|Other Study ID Numbers:||
N2015-01 ( Other Identifier: NANT Consortium )
|First Posted:||August 16, 2016 Key Record Dates|
|Last Update Posted:||January 31, 2023|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Individual participant data will be shared with the treating investigator and the study participant.|
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue