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Studying Chromosomes in Samples From Younger Patients With Neuroblastoma

Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01589341
Enrollment
300
Registered
2012-05-01
Start date
2012-04-30
Completion date
Unknown
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

Neuroblastoma

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival (OS)From the date of diagnosis to the date of death from any cause, assessed up to 5 yearsEstimated by the Kaplan-Meier method.

Secondary

MeasureTime frameDescription
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 yearsEstimated by the Kaplan-Meier method.
Incidence of metastatic relapses using cumulative incidencesUp to 5 yearsGrey's test and the model of Fine and Grey will be used for the evaluation of statistical significance.

Countries

United States

Outcome results

None listed

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