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Studying Chromosomes in Samples From Younger Patients With Neuroblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01589341
First received: April 29, 2012
Last updated: May 6, 2012
Last verified: April 2012
History of Changes
  Purpose

RATIONALE: 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.

PURPOSE: This research studies chromosomes in samples from younger patients with neuroblastoma.


Condition Intervention
Neuroblastoma
 Genetic: DNA analysis
Genetic: nucleic acid amplification
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Prognostic Impact of Segmental Chromosome Aberrations in Non MYCN Amplified Neuroblastomas in Different Age Groups

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival (OS) calculated from the date of diagnosis to the date of death from any cause estimated by the Kaplan-Meier method [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival (EFS) calculated from the date of diagnosis to the date of disease progression, death from any cause, or secondary neoplasm estimated by the Kaplan-Meier method [ Designated as safety issue: No ]
  • Incidence of metastatic relapses using cumulative incidences [ Designated as safety issue: No ]
  • Difference in patients with and without segmental aberrations using the log rank-test and Grey's test and the model of Fine and Grey for the evaluation of statistical significance [ Designated as safety issue: No ]
  • Interactions between age and segmental aberrations using Cox' regression model [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • No patients diagnosed before 1997 and after 2005
  • No lack of follow-up data

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No initial cytotoxic treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589341

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter F. Ambros, PhD Children's Cancer Research Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01589341     History of Changes
Other Study ID Numbers: CDR0000732465, COG-ANBL12B7
Study First Received: April 29, 2012
Last Updated: May 6, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
neuroblastoma

Additional relevant MeSH terms:
Chromosome Aberrations
Neuroblastoma
Pathologic Processes
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on June 18, 2013