Study of DNA in Blood Samples From Patients With Neuroblastoma
NCT ID: NCT00898391
Last Updated: 2016-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
329 participants
OBSERVATIONAL
2007-06-30
2016-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Ancillary-Correlative
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.
laboratory biomarker analysis
Correlative studies
polymerase chain reaction
Correlative studies
polyacrylamide gel electrophoresis
Correlative studies
DNA analysis
Correlative studies
Interventions
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laboratory biomarker analysis
Correlative studies
polymerase chain reaction
Correlative studies
polyacrylamide gel electrophoresis
Correlative studies
DNA analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Michael Hogarty, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Oncology Group
Monrovia, California, United States
Countries
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Other Identifiers
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NCI-2009-00686
Identifier Type: REGISTRY
Identifier Source: secondary_id
COG-NB2006-10
Identifier Type: OTHER
Identifier Source: secondary_id
NB2006-10
Identifier Type: OTHER
Identifier Source: secondary_id
ANBL07B1
Identifier Type: OTHER
Identifier Source: secondary_id
ANBL07B1
Identifier Type: -
Identifier Source: org_study_id
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