Studying Chromosomes in Samples From Younger Patients With Neuroblastoma
|ClinicalTrials.gov Identifier: NCT01589341|
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : May 18, 2016
|Condition or disease||Intervention/treatment|
|Neuroblastoma||Other: laboratory biomarker analysis|
I. Determine the impact on overall survival of patients with non-MYCN neuroblastoma below 18 months of age as compared to neuroblastoma patients above 18 months of age.
Archived DNA samples are analyzed for segmental chromosome aberrations by multiplex ligation-dependent probe amplification (MLPA), a polymerase chain reaction (PCR)-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||August 2012|
Archived DNA samples are analyzed (laboratory biomarker analysis) for segmental chromosome aberrations by MLPA, a PCR-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.
Other: laboratory biomarker analysis
- Overall survival (OS) [ Time Frame: From the date of diagnosis to the date of death from any cause, assessed up to 5 years ]Estimated by the Kaplan-Meier method.
- Event-free survival (EFS) [ Time Frame: From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years ]Estimated by the Kaplan-Meier method.
- Incidence of metastatic relapses using cumulative incidences [ Time Frame: Up to 5 years ]Grey's test and the model of Fine and Grey will be used for the evaluation of statistical significance.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589341
|United States, California|
|Children's Oncology Group|
|Monrovia, California, United States, 91006-3776|
|Principal Investigator:||Peter Ambros, MD||Children's Oncology Group|