logo Hematology/Oncology Research Studies: Open for Enrollment Date: 01/26/21

Category: ONCOLOGY

Neuroblastoma Classification Biology Studies

NCT#/Phase: NCT00904241
IRB#: 2001-058
Description: Clinical and biological factors have been shown to have prognostic value in neuroblastoma. Current therapeutic studies for neuroblastoma patients are tailored according to patient risk. In the Children’s Oncology Group (COG), risk-group assignment is currently based on INSS stage, age, MYCN copy number, tumor cell ploidy, and International Neuroblastoma Pathology Classification (INPC) tumor histopathology. However, additional biologic factors have also been reported to be predictive of outcome. This study serves as the infrastructure for rapid and reliable acquisition of proven prognostic markers currently used for risk stratification (MYCN copy number, tumor cell ploidy, tumor histology). In addition, this study will provide for the prospective analysis of the most promising additional prognostic markers including, but not necessarily limited to, chromosome 1p, 11q, 14q, and 17q allelic status, neurotrophin-related gene expression, and the presence of rare neuroblastoma cells in peripheral blood and/or bone marrow. The independent clinical significance of these biologic factors compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome will be determined. A reference bank containing genetically characterized frozen tumor tissue, tumor DNA and RNA, paired normal DNA, patient serum and tumor cell lines for future research studies will be maintained.
Inclusion: All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at COG institutions are eligible for this study.
Enrollment Status: Open for enrollment
Sponsor: COG
Principal Investigator(s): Carla Golden, MD
Contact(s): Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)
COG CRA Office (510-428-3885 x8334)
Study Link: https://clinicaltrials.gov/ct2/show/NCT00904241

UCSF Benioff Children's Hospital Oakland • 747 52nd Street, Oakland, California 94609 &bull Phone: (510) 428-3000