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
  Purpose

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.


Condition Intervention
Disseminated Neuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Other: laboratory biomarker analysis
Other: cytology specimen collection procedure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuroblastoma Biology Studies

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

frozen tumor tissue, Diagnostic bone marrow, Diagnostic blood


Estimated Enrollment: 4500
Study Start Date: November 2000
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm I
This laboratory study is looking at biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma.
Other: laboratory biomarker analysis
Correlative studies
Other: cytology specimen collection procedure
Correlative studies
Other Name: cytologic sampling

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904241

  Show 226 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Michael Hogarty, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00904241     History of Changes
Obsolete Identifiers: NCT00256763
Other Study ID Numbers: ANBL00B1, NCI-2009-00397, CDR0000078642, ANBL00B1, ANBL00B1, U10CA098543
Study First Received: May 16, 2009
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neuroblastoma
Ganglioneuroblastoma
Ganglioneuroma
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 April 17, 2014