Skip to content

Study of DNA in Blood Samples From Patients With Neuroblastoma

Analysis of Circulating MYCN DNA in Serum Samples Obtained From Patients With Neuroblastoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00898391
Enrollment
329
Registered
2009-05-12
Start date
2007-06-30
Completion date
2016-05-31
Last updated
2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disseminated Neuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4S Neuroblastoma

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.

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

GENETICpolymerase chain reaction

Correlative studies

Correlative studies

GENETICDNA analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCRUp to 6 months
Limits of the procedure in non-metastatic patients and in those with reduced tumor burdenUp to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026