Study of DNA in Blood Samples From Patients With Neuroblastoma
- Conditions
- Localized Unresectable NeuroblastomaRegional NeuroblastomaDisseminated NeuroblastomaLocalized Resectable NeuroblastomaRecurrent NeuroblastomaStage 4S Neuroblastoma
- Interventions
- Other: laboratory biomarker analysisGenetic: polymerase chain reactionGenetic: polyacrylamide gel electrophoresisGenetic: DNA analysis
- Registration Number
- NCT00898391
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
This research trial studies is deoxyribonucleic acid (DNA) in blood samples from patients with neuroblastoma. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
- Detailed Description
OBJECTIVES:
I. Perform in a blind study a multicentric study by analyzing serum from patients at diagnosis (with a known tumor v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) status determined in the Children's Oncology Group \[COG\] reference lab), in order to confirm our previous data and to define the most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases.
II. Define the limits of the procedure in non-metastatic patients and in those with reduced tumor burden (International Neuroblastoma Staging System \[INSS\] stage 1 and 2).
OUTLINE:
Circulating DNA is extracted from serum. Polymerase chain reaction (PCR) amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 329
-
Serum samples from neuroblastoma (NB) patients obtained through the COG (and legacy Children's Cancer Group [CCG]/Pediatric Oncology Group [POG] Biology Studies)
- The MYCN status on corresponding tumors have been determined using standard techniques; the panel of samples must be obtained from NB patients with and without MYCN amplification tumors
-
Cases will be drawn from clinical subsets at greatest likelihood to benefit from this testing ability, stage 1 and 2 NBs (both infants and toddlers), stage 4 patients under 18 months of age, and 4S patients
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-Correlative polyacrylamide gel electrophoresis Circulating DNA is extracted from serum. PCR amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed. Ancillary-Correlative DNA analysis Circulating DNA is extracted from serum. PCR amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed. Ancillary-Correlative laboratory biomarker analysis Circulating DNA is extracted from serum. PCR amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed. Ancillary-Correlative polymerase chain reaction Circulating DNA is extracted from serum. PCR amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.
- Primary Outcome Measures
Name Time Method Limits of the procedure in non-metastatic patients and in those with reduced tumor burden Up to 6 months Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCR Up to 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Oncology Group
🇺🇸Monrovia, California, United States