Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups
N/A
18 Years
Both
Neuroblastoma
Trial Information
Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups
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.
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
Type of Study:
Observational
Study Design:
Time Perspective: Retrospective
Outcome Measure:
Overall survival (OS)
Outcome Description:
Estimated by the Kaplan-Meier method.
Outcome Time Frame:
From the date of diagnosis to the date of death from any cause, assessed up to 5 years
Safety Issue:
No
Principal Investigator
Peter Ambros
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
ANBL12B7
NCT ID:
NCT01589341
Start Date:
April 2012
Completion Date:
Related Keywords:
- Neuroblastoma
- Chromosome Aberrations
- Neuroblastoma
Name | Location |
|---|---|
| Children's Oncology Group | Arcadia, California 91006-3776 |
