Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

This study is currently recruiting participants.
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00904241
First received: May 16, 2009
Last updated: February 20, 2014
Last verified: February 2014

May 16, 2009
February 20, 2014
November 2000
January 2100   (final data collection date for primary outcome measure)
  • Factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
  • Prevalence of 1p, 11q, 14q loss of heterozygosity and gain of 17q [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
  • Expression of nerve growth factor and its high affinity (Trk-A) and low affinity (p75NTR) receptors [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
  • Telomerase activity [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
  • Comparison of the independent clinical significance of biological factors with MYCN amplification, International Neuroblastoma Staging system stage, age, and histologic variables in predicting response to treatment or outcome [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
  • Factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) [ Designated as safety issue: No ]
  • Prevalence of 1p, 11q, 14q loss of heterozygosity and gain of 17q [ Designated as safety issue: No ]
  • Expression of nerve growth factor and its high affinity (Trk-A) and low affinity (p75NTR) receptors [ Designated as safety issue: No ]
  • Telomerase activity [ Designated as safety issue: No ]
  • Comparison of the independent clinical significance of biological factors with MYCN amplification, International Neuroblastoma Staging system stage, age, and histologic variables in predicting response to treatment or outcome [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00904241 on ClinicalTrials.gov Archive Site
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Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Neuroblastoma Biology Studies

This laboratory study is looking at biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

OBJECTIVES:

I. Evaluate the factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) in patients with newly diagnosed neuroblastoma or ganglioneuroblastoma.

II. Assess the prevalence of 1p, 11q, 14q loss of heterozygosity and gain of 17q; the expression of nerve growth factor and its high affinity (Trk-A) and low affinity (p75NTR) receptors; and telomerase activity in these patients.

III. Compare the independent clinical significance of these biological factors with MYCN amplification, International Neuroblastoma Staging system stage, age, and histologic variables in predicting response to treatment or outcome in these patients.

IV. Maintain a reference bank containing clinically and genetically characterized frozen tumor tissue, tumor DNA and RNA, tumor touch preparations, histology slides and blocks, cell lines, and paired normal DNA obtained at time of diagnosis, second-look surgery, and relapse for future research studies.

V. Build a database of known biological prognostic factors for patients on therapeutic studies.

OUTLINE: This is a multicenter study.

Patients are stratified according to International Neuroblastoma Staging System stage (stage 1 vs stage 2A vs stage 2B vs stage 3 vs stage 4 vs stage 4S) and age (under 365 days vs 365 days and over). Tumor samples are obtained at the time of surgery (diagnosis). Tumor samples may also be obtained at the time of second-look surgery and/or relapse. Blood and bone marrow samples are also obtained. MYCN copy number is analyzed by fluorescent in situ hybridization (FISH). Tumor cell ploidy is determined by flow cytometric analysis. Allelic status of 1p36, 11q23, and 14q32 is determined by multiplexed fluorescence polymerase chain reaction (PCR). Real-time quantitative PCR and FISH are used to determine 17q gain. Neurotrophin and neurotrophin receptor expression and the level of telomerase RNA expression is determined by reverse transcription-PCR. Telomerase activity is assessed by a telomeric repeat amplification protocol assay in patients with stage 2 or 4S disease.

Patients are followed within 2 weeks and then annually (if not on a concurrent therapeutic study).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

frozen tumor tissue, Diagnostic bone marrow, Diagnostic blood

Non-Probability Sample

All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at COG institutions are eligible for this study.

  • Disseminated Neuroblastoma
  • Localized Resectable Neuroblastoma
  • Localized Unresectable Neuroblastoma
  • Regional Neuroblastoma
  • Stage 4S Neuroblastoma
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: cytology specimen collection procedure
    Correlative studies
    Other Name: cytologic sampling
Arm I
This laboratory study is looking at biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma.
Interventions:
  • Other: laboratory biomarker analysis
  • Other: cytology specimen collection procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4500
Not Provided
January 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of neuroblastoma or ganglioneuroblastoma within the past two weeks
  • No relapsed neuroblastoma at enrollment
  • No prior enrollment on a front-line COG therapeutic study (low-, intermediate-, or high-risk)
Both
up to 30 Years
No
Not Provided
United States,   Australia,   Canada,   New Zealand,   Puerto Rico,   Switzerland
 
NCT00904241
ANBL00B1, NCI-2009-00397, CDR0000078642, ANBL00B1, ANBL00B1, U10CA098543
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Michael Hogarty, MD Children's Oncology Group
Children's Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP