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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01961 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000732465 | Other Identifier | Clinical Trials.gov | |
| COG-ANBL12B7 | Other Identifier | Children's Oncology Group |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Correlative studies | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Estimated by the Kaplan-Meier method. | From the date of diagnosis to the date of death from any cause, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | Estimated by the Kaplan-Meier method. | From the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm, assessed up to 5 years |
| Incidence of metastatic relapses using cumulative incidences |
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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
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
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Neuroblastoma patient samples
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| Name | Affiliation | Role |
|---|---|---|
| Peter Ambros, MD | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Monrovia | California | 91006-3776 | United States |
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| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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tumor tissue
Grey's test and the model of Fine and Grey will be used for the evaluation of statistical significance. |
| Up to 5 years |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |