Study of DNA in Blood Samples From Patients With Neuroblastoma
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|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|
|Actual Primary Completion Date :||May 2016|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|