Study of DNA in Blood Samples From Patients With Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00898391|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 18, 2016
|Condition or disease||Intervention/treatment|
|Disseminated Neuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Recurrent Neuroblastoma Regional Neuroblastoma Stage 4S Neuroblastoma||Other: laboratory biomarker analysis Genetic: polymerase chain reaction Genetic: polyacrylamide gel electrophoresis Genetic: DNA analysis|
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).
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.
|Study Type :||Observational|
|Actual Enrollment :||329 participants|
|Official Title:||Analysis of Circulating MYCN DNA in Serum Samples Obtained From Patients With Neuroblastoma|
|Study Start Date :||June 2007|
|Primary Completion Date :||May 2016|
|Study Completion Date :||May 2016|
U.S. FDA Resources
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.
Other: laboratory biomarker analysis
Correlative studiesGenetic: polymerase chain reaction
Other Name: PCRGenetic: polyacrylamide gel electrophoresis
Other Name: electrophoresis, polyacrylamide gelGenetic: DNA analysis
- Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCR [ Time Frame: Up to 6 months ]
- Limits of the procedure in non-metastatic patients and in those with reduced tumor burden [ Time Frame: Up to 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898391
|United States, California|
|Children's Oncology Group|
|Monrovia, California, United States, 91006-3776|
|Principal Investigator:||Michael Hogarty, MD||Children's Oncology Group|