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


N/A
N/A
18 Years
Open (Enrolling)
Both
Neuroblastoma

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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