Study of DNA in Blood Samples From Patients With Neuroblastoma

Children's Oncology Group

Status: Completed

Conditions: Regional Neuroblastoma; Recurrent Neuroblastoma; Localized Unresectable Neuroblastoma; Stage 4S Neuroblastoma; Disseminated Neuroblastoma; Localized Resectable Neuroblastoma

Treatments: Genetic: DNA analysis; Genetic: polyacrylamide gel electrophoresis; Genetic: polymerase chain reaction; Other: laboratory biomarker analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00898391

NB2006-10 (Other Identifier)

COG-NB2006-10 (Other Identifier)

ANBL07B1 (Other Identifier)

NCI-2009-00686 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 329 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

329 participants in 1 patient group

Ancillary-Correlative

Description:

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.

Treatment:

Genetic: polymerase chain reaction

Other: laboratory biomarker analysis

Genetic: polyacrylamide gel electrophoresis

Genetic: DNA analysis