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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00904241
Registration number
NCT00904241
Ethics application status
Date submitted
16/05/2009
Date registered
19/05/2009
Date last updated
16/04/2024
Titles & IDs
Public title
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
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Scientific title
Neuroblastoma Biology Studies
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Secondary ID [1]
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NCI-2009-00397
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Secondary ID [2]
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ANBL00B1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ganglioneuroblastoma
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Localized Resectable Neuroblastoma
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Localized Unresectable Neuroblastoma
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Regional Neuroblastoma
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Stage 4 Neuroblastoma
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Stage 4S Neuroblastoma
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Other
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Cancer
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Children's - Brain
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Cancer
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Brain
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Cytology Specimen Collection Procedure
Other interventions - Laboratory Biomarker Analysis
Ancillary-Correlative (cytology specimen collection) - Patients undergo collection of blood, tissue, and bone marrow samples for analysis via RT-PCR, quantitative PCR, flow cytometry, and FISH.
Other interventions: Cytology Specimen Collection Procedure
Correlative studies
Other interventions: Laboratory Biomarker Analysis
Correlative studies
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology)
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Assessment method [1]
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Life tables, Kaplan-Meier survival curves, log-rank tests, and Cox regression will be used to explore the relationship of laboratory variables to outcome.
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Timepoint [1]
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Up to 3 years
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Primary outcome [2]
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Prevalence of 1p, 11q, 14q, and 17q allelic status
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Assessment method [2]
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These biological variables will be analyzed for independent clinical significance compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
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Timepoint [2]
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Up to 3 years
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Primary outcome [3]
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MYCN copy number by quantitative PCR
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Assessment method [3]
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These biological variables will be analyzed for independent clinical significance compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
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Timepoint [3]
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Up to 3 years
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Primary outcome [4]
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Expression pattern of neurotrophin-related genes in diagnostic neuroblastoma tumors
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Assessment method [4]
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These biological variables will be analyzed for independent clinical significance compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
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Timepoint [4]
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Up to 3 years
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Primary outcome [5]
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Presence of rare tumor cells in biological specimens by RT-PCR
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Assessment method [5]
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These biological variables will be analyzed for independent clinical significance compared to MYCN amplification, INSS stage, age, ploidy, and histologic variables in predicting either response to treatment or outcome.
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Timepoint [5]
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Up to 3 years
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Primary outcome [6]
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Database of the known biologic prognostic factors for patients on therapeutic studies
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Assessment method [6]
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During the testing for treatment effect in Phase III trials, the biologic prognostic factors may be needed for adjustment in the Cox regression model-building process.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [1]
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MYCN status per tumor
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Assessment method [1]
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Cross tabulations of MYCN status per tumor versus MYCN status per blood will be generated, the percentage concordant and the percentage discordant will be calculated, and receiver operating characteristic (ROC) analyses will be performed. Kaplan-Meier curves of MYCN status per blood will be generated, and a logrank test comparison performed. The prognostic ability of MYCN status per tumor versus MYCN status per blood will be tested in a multivariable Cox model.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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MYCN status per blood
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Assessment method [2]
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Cross tabulations of MYCN status per tumor versus MYCN status per blood will be generated, the percentage concordant and the percentage discordant will be calculated, and ROC analyses will be performed. Kaplan-Meier curves of MYCN status per blood will be generated, and a logrank test comparison performed. The prognostic ability of MYCN status per tumor versus MYCN status per blood will be tested in a multivariable Cox model.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Incidence of OMA
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Assessment method [3]
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Descriptive analysis will be performed.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Incidence of spinal cord compression
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Assessment method [4]
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Descriptive analysis will be performed.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Presentation with multifocal primary tumors
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Assessment method [5]
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Descriptive analysis will be performed.
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Timepoint [5]
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Up to 3 years
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Eligibility
Key inclusion criteria
* All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
* There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
* Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
* Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
* It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
* Exceptions
* In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
* For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
* For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
* Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
* Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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Minimum age
No limit
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/11/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
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Sample size
Target
10000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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John Hunter Children's Hospital - Hunter Regional Mail Centre
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Sydney Children's Hospital - Randwick
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The Children's Hospital at Westmead - Westmead
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Royal Brisbane and Women's Hospital - Herston
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Royal Children's Hospital-Brisbane - Herston
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Queensland Children's Hospital - South Brisbane
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Women's and Children's Hospital-Adelaide - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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Perth Children's Hospital - Perth
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2310 - Hunter Regional Mail Centre
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2031 - Randwick
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2145 - Westmead
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Recruitment postcode(s) [4]
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4029 - Herston
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4101 - South Brisbane
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Recruitment postcode(s) [6]
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5006 - North Adelaide
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Recruitment postcode(s) [7]
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3052 - Parkville
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Recruitment postcode(s) [8]
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6008 - Perth
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Recruitment postcode(s) [9]
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6009 - Perth
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Recruitment outside Australia
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Alabama
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Lausanne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This research trial studies 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.
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Trial website
https://clinicaltrials.gov/study/NCT00904241
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Hogarty
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Address
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Children's Oncology Group
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00904241
Download to PDF