Studying Chromosomes in Samples From Younger Patients With Neuroblastoma
Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups
4 other identifiers
observational
300
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 29, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedMay 18, 2016
May 1, 2016
4 months
April 29, 2012
May 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
Incidence of metastatic relapses using cumulative incidences
Up to 5 years
Study Arms (1)
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.
Interventions
Eligibility Criteria
Neuroblastoma patient samples
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Oncology Group
Monrovia, California, 91006-3776, United States
Biospecimen
tumor tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Ambros, MD
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2012
First Posted
May 1, 2012
Study Start
April 1, 2012
Primary Completion
August 1, 2012
Last Updated
May 18, 2016
Record last verified: 2016-05