DNA Analysis of Tumor Tissue Samples From Patients With Diffuse Brain Stem Glioma - Full Text View

Sponsor:	St. Jude Children's Research Hospital
Information provided by (Responsible Party):	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00899834

Purpose

This multi-institutional study will prospectively collect tumor and constitutional tissue samples from patients with diffuse brainstem glioma and other types of brainstem gliomas either during therapy or at autopsy to perform an extensive analysis of genetic and molecular abnormalities in these tumors.

Condition
Brain Tumors Central Nervous System Tumors

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Comprehensive Molecular Analysis of Tumor Samples Derived From Patients With Diffuse Brainstem Glioma - A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

DNA gains and losses and RNA expression in tumor samples and normal tissue [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Genome-wide expression patterns of RNA in tumor samples and normal tissue as assessed by Affymetrix gene expression profiling [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Validation of results of the genome-wide analysis [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Mutations in candidate tumor-suppressor genes and oncogenes as assessed by direct sequencing analysis of tumor DNA [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Confirmation of the tumor-specific nature of candidate tumor-suppressor gene and oncogene mutation as assessed by the correspondent constitutional DNA [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Confirmation of genomic gains or losses as assessed by fluorescence in situ hybridization (FISH) performed on tissue microarray (TMA) using non-neoplastic brain tissue [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Protein expression patterns as assessed by immunohistochemistry or western blot compared to normal brain stem tissue [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess aspects associated with this procedure, including potential benefits and drawbacks [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

tumor and constitutional tissue samples from patients with diffuse brainstem glioma and other types of brainstem gliomas

Estimated Enrollment:	150
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts
Tumor Samples fresh-frozen and fixed tumor samples and correspondent normal tissue from patients affected with this tumor.(peripheral blood is applicable only to patients with focal brainstem gliomas and patients who undergo biopsy of a diffuse brainstem glioma at diagnosis)

Detailed Description:

Since very little is known about the biology of diffuse brainstem glioma, the goal of this protocol is to undertake a systematic analysis of DNA abnormalities, and of RNA and protein expression in prospectively collected fresh-frozen and fixed tumor samples and correspondent normal tissue from patients affected with this tumor.

OBJECTIVES:

Perform genome-wide analysis of DNA gains and losses and RNA expression in tumor samples and normal tissue from patients with diffuse brain stem glioma.
Identify regions of genomic gain or loss using either array comparative genomic hybridization or single nucleotide polymorphism arrays.
Investigate genome-wide expression patterns of RNA derived from tumor samples and normal tissue from these patients via Affymetrix gene expression profiling.
Validate the results of the genome-wide analysis by conducting further evaluation of candidate genes or by investigating the expression of relevant gene products at the RNA and protein levels.
Perform analysis of mutations in candidate tumor-suppressor genes and oncogenes (including whole genome sequencing studies)using direct sequence analysis of tumor DNA and confirm the tumor-specific nature of these mutations by analyzing the correspondent constitutional DNA.
Confirm genomic gains or losses identified by means of fluorescence in situ hybridization (FISH) performed on tissue microarray using non-neoplastic brain tissue from each patient as control when available.
Explore protein expression patterns identified by immunohistochemistry or western blot and compare them to normal brain stem tissue.
To obtain a follow-up (questionnaire and/or telephone interview) after autopsy with parent(s), legal guardian(s), or family members of research participants in the United States to assess aspects associated with this procedure, including potential benefits and drawbacks

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Fresh-frozen and fixed tumor samples and correspondent normal tissue from patients affected with this tumor (peripheral blood is applicable only to patients with focal brainstem gliomas and patients who undergo biopsy of a diffuse brainstem glioma at diagnosis)

Criteria

Inclusion Criteria

Patients of any age with clinical and radiologic diagnosis of diffuse brainstem glioma
Patients with other high-grade gliomas originating in the brainstem
Patients with focal gliomas (WHO grade I/II) of the brainstem
Enrollment in the current version of the St. Jude Tissue Bank protocol for patients whose tissue samples were obtained at diagnosis and who received treatment at SJCRH, or correspondent tissue banking consent for patients treated in other institutions if tissue was obtained prior to death (as applicable, depending on the standard of each institution)

Exclusion Criteria

Patients with any type of infiltrative low-grade (WHO grade II) or high-grade glioma (WHO grade III and IV) originating outside the brainstem
Patients harboring primary brainstem tumors with other histologic diagnoses (e.g., PNET)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899834

Contacts

Contact: Alberto Broniscer, MD

866-278-5833

info@stjude.org

Locations

United States, California
Stanford University Medical Center	Recruiting
Palo Alto, California, United States, 94305
Contact: Paul Fisher, MD 650-725-8630 pfisher@stanford.edu
Principal Investigator: Paul Fisher, MD
United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: Alberto Broniscer, MD 866-278-5833
Principal Investigator: Alberto Broniscer, MD
United States, Washington
Seattle Children's Hospital	Recruiting
Seattle, Washington, United States, 98105
Contact: Jeffrey R. Geyer, MD 206-987-6664
Principal Investigator: Jeffrey R. Geyer, MD

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Alberto Broniscer, MD

St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00899834 History of Changes
Other Study ID Numbers:	NBTP02-SJ
Study First Received:	May 9, 2009
Last Updated:	September 27, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:

adult brain stem glioma
childhood brain stem glioma

Additional relevant MeSH terms:

Brain Neoplasms
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on February 09, 2012