NCT00899834

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

9.2 years

First QC Date

May 9, 2009

Last Update Submit

July 25, 2016

Conditions

Brain TumorsCentral Nervous System Tumors

Keywords

adult brain stem gliomachildhood brain stem glioma

Outcome Measures

Primary Outcomes (7)

  • DNA gains and losses and RNA expression in tumor samples and normal tissue

    Tissue samples will be obtained at autopsy.

    at autopsy

  • Genome-wide expression patterns of RNA in tumor samples and normal tissue as assessed by Affymetrix gene expression profiling

    Tissue samples will be obtained at autopsy.

    at autopsy

  • Validation of results of the genome-wide analysis

    Tissue samples will be obtained at autopsy.

    at autopsy

  • Mutations in candidate tumor-suppressor genes and oncogenes as assessed by direct sequencing analysis of tumor DNA

    Tissue samples will be obtained at autopsy.

    at autopsy

  • Confirmation of the tumor-specific nature of candidate tumor-suppressor gene and oncogene mutation as assessed by the correspondent constitutional DNA

    Tissue samples will be obtained at autopsy.

    at autopsy

  • Confirmation of genomic gains or losses as assessed by fluorescence in situ hybridization (FISH) performed on tissue microarray (TMA) using non-neoplastic brain tissue

    Tissue samples will be obtained at autopsy.

    at autopsy

  • Protein expression patterns as assessed by immunohistochemistry or western blot compared to normal brain stem tissue

    Tissue samples will be obtained at autopsy.

    at autopsy

Secondary Outcomes (1)

  • Assess aspects associated with this procedure, including potential benefits and drawbacks

    at autopsy

Study Arms (1)

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)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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)

You may qualify if:

  • 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 St. Jude Children's Research Hospital (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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Brain NeoplasmsCentral Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Alberto Broniscer, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

June 1, 2006

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

US(3)