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Study of DNA in Blood Samples From Patients With Neuroblastoma

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00898391
Collaborator
National Cancer Institute (NCI) (NIH)
329
Enrollment
1
Location
107
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

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 Phase
  • Other: laboratory biomarker analysis
  • Genetic: polymerase chain reaction
  • Genetic: polyacrylamide gel electrophoresis
  • Genetic: DNA analysis

Detailed Description

OBJECTIVES:

  1. 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.

  2. 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 :
Jun 1, 2007
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm 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 Names:
  • PCR

    • Genetic: polyacrylamide gel electrophoresis
    Correlative studies
    Other Names:
  • 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 [Up to 6 months]

    2. Limits of the procedure in non-metastatic patients and in those with reduced tumor burden [Up to 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00898391
    Other Study ID Numbers:
    • ANBL07B1
    • NCI-2009-00686
    • COG-NB2006-10
    • NB2006-10
    • ANBL07B1
    First Posted:
    May 12, 2009
    Last Update Posted:
    May 18, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Neuroblastoma

    Study Results

    No Results Posted as of May 18, 2016