Studying Chromosomes in Samples From Younger Patients With Neuroblastoma

Children's Oncology Group

Status: Completed

Conditions: Neuroblastoma

Treatments: Other: laboratory biomarker analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01589341

NCI-2012-01961 (Registry Identifier)

COG-ANBL12B7 (Other Identifier)

CDR0000732465 (Other Identifier)

ANBL12B7

Details and patient eligibility

About

This research studies chromosomes in samples from younger patients with neuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Full description

OBJECTIVES:

I. Determine the impact on overall survival of patients with non-MYCN neuroblastoma below 18 months of age as compared to neuroblastoma patients above 18 months of age.

OUTLINE:

Archived DNA samples are analyzed for segmental chromosome aberrations by multiplex ligation-dependent probe amplification (MLPA), a polymerase chain reaction (PCR)-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.

Enrollment: 300 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Samples from neuroblastoma patients who, according to risk stratification, did not receive cytotoxic treatment and did never receive chemotherapy and are in complete response (CR) OR patients who, according to risk stratification, did not receive cytotoxic treatment initially, but had a localized or a systemic (stage Ms or M) relapse with or without following chemotherapy

  • Low-risk Children Oncology Group (COG) designation: no initial cytotoxic treatment, any stage, any age, any outcome

• DNA from untreated neuroblastoma tumor samples (from patients in the age group below and from patients in the age group above 1.5 years of age) available from the COG, Europe, Israel, and Japan

• No MYCN amplification

• No Schwann cell stroma-rich tumors

• No tumor cell content below 60%

• No DOT

• No patients diagnosed before 1997 and after 2005

• No lack of follow-up data

• See Disease Characteristics

• No initial cytotoxic treatment

Trial design

300 participants in 1 patient group

Correlative studies

Description:

Archived DNA samples are analyzed (laboratory biomarker analysis) for segmental chromosome aberrations by MLPA, a PCR-based technique. The following genomic regions are being studied: 1p, 1q, 3p, 4p, 7q, 9p, 11q, and 17q, as are the copy numbers of MYCN, NAG, DDX1, and ALK genes.

Treatment:

Other: laboratory biomarker analysis