Studying Chromosomes in Samples From Younger Patients With Neuroblastoma

Completed

• Conditions: Neuroblastoma
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01589341
• Lead Sponsor: Children's Oncology Group

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-29
• Study First Submitted QC: 2012-04-29
• Study First Posted: 2012-05-01
• Primary Completion: 2012-08
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Correlative studies	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	From the date of diagnosis to the date of death from any cause, assessed up to 5 years	Estimated by the Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Incidence of metastatic relapses using cumulative incidences	Up to 5 years	Grey's test and the model of Fine and Grey will be used for the evaluation of statistical significance.
Event-free survival (EFS)	From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years	Estimated by the Kaplan-Meier method.

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States