Biomarkers in Tumour Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

Official Title

Neuroblastoma Biology Studies

Summary:

This research trial studies biomarkers in tumour tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumour tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Trial Description

Primary Outcome:

• Factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumour histology)
• Prevalence of 1p, 11q, 14q, and 17q allelic status
• MYCN copy number by quantitative PCR
• Expression pattern of neurotrophin-related genes in diagnostic neuroblastoma tumours
• Presence of rare tumour cells in biological specimens by RT-PCR
• Database of the known biologic prognostic factors for patients on therapeutic studies

Secondary Outcome:

• MYCN status per tumour
• MYCN status per blood
• Incidence of OMA
• Incidence of spinal cord compression
• Presentation with multifocal primary tumours

Primary Objectives:

• To prospectively analyze the factors that are currently used for risk-group assignment (v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog [MYCN] copy number by fluorescent in situ hybridization [FISH], deoxyribonucleic acid [DNA] content by flow cytometry, and tumour histology using the International Neuroblastoma Pathologic Classification System) in neuroblastoma tumours at the time of diagnosis.
• To maintain a reference bank containing clinically and genetically characterized frozen tumour tissue, tumour DNA and ribonucleic acid (RNA), histology slides and paraffin blocks, neuroblastoma-derived cell lines, patient serum and paired normal DNA obtained at the time of diagnosis, at the time of second-look surgery and at the time of relapse for future research studies.
• To prospectively analyze 1p, 11q, 14q and 17q allelic status, MYCN copy number by quantitative polymerase chain reaction (PCR); and the expression pattern of neurotrophin-related genes in diagnostic neuroblastoma tumours, and assay for the presence of rare tumour cells in biological specimens by reverse transcription (RT)-PCR; these biological variables will be analyzed for independent clinical significance compared to MYCN amplification, International Neuroblastoma Staging System (INSS) stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
• To build a database of the known biologic prognostic factors for patients on therapeutic studies.
• To serve as a Registry for neuroblastoma patients whose tumours demonstrate clinical and genetic features defined as ?Low Risk? for treatment failure in the absence of adjuvant therapy.

Secondary Objectives:

• To prospectively analyze the concordance between detection of MYCN amplification in tumour samples and quantitative detection of MYCN DNA in serum, and to analyze the prognostic significance of MYCN amplification as detected in serum samples.
• To build a database that includes information regarding the presentation and natural history of neuroblastoma-associated health problems including but not limited to opsoclonus myoclonus ataxia (OMA) and/or spinal cord compression.

Outline:
Patients undergo collection of blood, tissue, and bone marrow samples for analysis via RT-PCR, quantitative PCR, flow cytometry, and FISH. After completion of study, patients are followed up periodically.

View this trial on ClinicalTrials.gov