Clinical Trials (PDQ®)
|No phase specified||Biomarker/Laboratory analysis, Tissue collection/Repository||Active||Under 31||NCI, Other||ANBL00B1|
NCI-2009-00397, CDR0000078642, U10CA098543, COG-ANBL00B1, NCT00904241
This laboratory study is looking at biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Further Study Information
I. Evaluate the factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) in patients with newly diagnosed neuroblastoma or ganglioneuroblastoma.
II. Assess the prevalence of 1p, 11q, 14q loss of heterozygosity and gain of 17q; the expression of nerve growth factor and its high affinity (Trk-A) and low affinity (p75NTR) receptors; and telomerase activity in these patients.
III. Compare the independent clinical significance of these biological factors with MYCN amplification, International Neuroblastoma Staging system stage, age, and histologic variables in predicting response to treatment or outcome in these patients.
IV. Maintain a reference bank containing clinically and genetically characterized frozen tumor tissue, tumor DNA and RNA, tumor touch preparations, histology slides and blocks, cell lines, and paired normal DNA obtained at time of diagnosis, second-look surgery, and relapse for future research studies.
V. Build a database of known biological prognostic factors for patients on therapeutic studies.
OUTLINE: This is a multicenter study.
Patients are stratified according to International Neuroblastoma Staging System stage (stage 1 vs stage 2A vs stage 2B vs stage 3 vs stage 4 vs stage 4S) and age (under 365 days vs 365 days and over). Tumor samples are obtained at the time of surgery (diagnosis). Tumor samples may also be obtained at the time of second-look surgery and/or relapse. Blood and bone marrow samples are also obtained. MYCN copy number is analyzed by fluorescent in situ hybridization (FISH). Tumor cell ploidy is determined by flow cytometric analysis. Allelic status of 1p36, 11q23, and 14q32 is determined by multiplexed fluorescence polymerase chain reaction (PCR). Real-time quantitative PCR and FISH are used to determine 17q gain. Neurotrophin and neurotrophin receptor expression and the level of telomerase RNA expression is determined by reverse transcription-PCR. Telomerase activity is assessed by a telomeric repeat amplification protocol assay in patients with stage 2 or 4S disease.
Patients are followed within 2 weeks and then annually (if not on a concurrent therapeutic study).
- Diagnosis of neuroblastoma or ganglioneuroblastoma within the past two weeks
- No relapsed neuroblastoma at enrollment
- No prior enrollment on a front-line COG therapeutic study (low-, intermediate-, or high-risk)
Trial Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
|Michael Hogarty, MD||Principal Investigator|
|Saint Peter's University Hospital|
|Stanley Calderwood||Ph: 732-745-8600ext6163|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00904241
ClinicalTrials.gov processed this data on February 20, 2014
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