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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

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.


Study Design

Study Type : Observational
Actual Enrollment : 329 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
Other: laboratory biomarker analysis
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Name: PCR
Genetic: polyacrylamide gel electrophoresis
Correlative studies
Other Name: electrophoresis, polyacrylamide gel
Genetic: DNA analysis
Correlative studies


Outcome Measures

Primary Outcome Measures :
  1. Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCR [ Time Frame: Up to 6 months ]
  2. Limits of the procedure in non-metastatic patients and in those with reduced tumor burden [ Time Frame: Up to 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with neuroblastoma treated at a COG participating site.
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael Hogarty, MD Children's Oncology Group
More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00898391     History of Changes
Other Study ID Numbers: ANBL07B1
NCI-2009-00686 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-NB2006-10 ( Other Identifier: Children's Oncology Group )
NB2006-10 ( Other Identifier: Children's Oncology Group )
ANBL07B1 ( Other Identifier: CTEP )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue