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Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors

Primary Purpose

Brain Tumors, Central Nervous System Tumors

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
DNA ploidy analysis
comparative genomic hybridization
cytogenetic analysis
fluorescence in situ hybridization
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Brain Tumors focused on measuring untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood medulloblastoma

Eligibility Criteria

undefined - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed primary CNS malignancy consistent with primitive neuroectodermal tumor, medulloblastoma, or atypical teratoid/rhabdoid tumor Must be entered on CCG-9921, CCG-9931, CCG-A9961, CCG-99703 or other front-line studies developed from CCG-90024 or CCG-90025 Retrospective specimens also obtained from CCG-921, CCG-923, CCG-9892, CCG-9921, and CCG-9931 PATIENT CHARACTERISTICS: Age: Under 21 Performance status: See Disease Characteristics Life expectancy: See Disease Characteristics Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: See Disease Characteristics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery Not specified

Sites / Locations

  • Phoenix Children's Hospital
  • Southern California Permanente Medical Group
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • Jonsson Comprehensive Cancer Center at UCLA
  • Children's Hospital Central California
  • Children's Hospital of Orange County
  • Santa Barbara Cottage Children's Hospital
  • Children's Hospital Center for Cancer and Blood Disorders
  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
  • Alfred I. duPont Hospital for Children
  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
  • Children's National Medical Center
  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
  • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Advocate Lutheran General Cancer Care Center
  • Swedish-American Regional Cancer Center
  • Simmons Cooper Cancer Institute
  • St. Vincent Indianapolis Hospital
  • Blank Children's Hospital
  • Holden Comprehensive Cancer Center at University of Iowa
  • Kosair Children's Hospital
  • Butterworth Hospital at Spectrum Health
  • CCOP - Kalamazoo
  • Breslin Cancer Center at Ingham Regional Medical Center
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
  • Masonic Cancer Center at University of Minnesota
  • Children's Hospitals and Clinics of Minnesota - St. Paul
  • Children's Mercy Hospital
  • CCOP - Nevada Cancer Research Foundation
  • Monmouth Medical Center
  • Carol G. Simon Cancer Center at Morristown Memorial Hospital
  • Overlook Hospital
  • Newark Beth Israel Medical Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • CCOP - MeritCare Hospital
  • Cincinnati Children's Hospital Medical Center
  • Rainbow Babies and Children's Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Nationwide Children's Hospital
  • Dayton Children's - Dayton
  • Tod Children's Hospital
  • Penn State Children's Hospital
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh of UPMC
  • Avera Cancer Institute
  • East Tennessee Children's Hospital
  • Texas Tech University Health Sciences Center School of Medicine - Amarillo
  • Dell Children's Medical Center of Central Texas
  • Methodist Children's Hospital of South Texas
  • Primary Children's Medical Center
  • Deaconess Medical Center
  • Gundersen Lutheran Center for Cancer and Blood
  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  • Marshfield Clinic - Marshfield Center
  • Princess Margaret Hospital for Children
  • Children's & Women's Hospital of British Columbia
  • IWK Health Centre
  • Allan Blair Cancer Centre at Pasqua Hospital
  • Saskatoon Cancer Centre at the University of Saskatchewan

Outcomes

Primary Outcome Measures

Frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS
Estimate the frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS diagnosed in children

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 5, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003096
Brief Title
Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors
Official Title
Molecular Biology of Pediatric Brain Tumors
Study Type
Observational

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Analyzing the number and structure of genes found in a child's cancer cells may help doctors improve methods of diagnosing and treating children with brain tumors. PURPOSE: This clinical trial is studying the number and structure of genes in cancer cells of children with brain tumors.
Detailed Description
OBJECTIVES: Determine the chromosomal gains and losses by DNA ploidy analysis and comparative genomic hybridization in patients with primitive neuroectodermal tumors or medulloblastomas. Determine the frequency of specific chromosomal abnormalities, including deletions of chromosomal regions 6, 17, and 22, in these patients. Perform a statistical analysis to determine possible associations of chromosomal abnormalities and DNA ploidy with patient age, tumor histology, tumor location, extent of disease, and event-free survival. OUTLINE: DNA ploidy analysis will be performed to determine the overall level of aneuploidy. The results are compared to the comparative genomic hybridization (CGH) analysis, which is used to demonstrate tumor-specific losses or gains, including amplification, of specific chromosomal regions. Tumors are also screened for specific abnormalities by fluorescent in situ hybridization (FISH), which detects chromosomal rearrangements, including balanced translocations, deletions, amplifications, etc. PCR-based microsatellite polymorphism analysis may also be performed. Primitive neuroectodermal tumors (PNETs) are screened by FISH with a distal 17p13.3 cosmid and a 17q25 cosmid to identify tumors with a 17p deletion. Atypical teratoid/rhabdoid tumors and PNETs without a 17p deletion are screened by FISH with a series of cosmids from 22q11.2. PNETs are also screened by interphase FISH with cosmids from chromosome 6 to identify tumors with deletions. Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. PROJECTED ACCRUAL: This study will accrue 360 specimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors, Central Nervous System Tumors
Keywords
untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood medulloblastoma

7. Study Design

Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
DNA ploidy analysis
Intervention Type
Genetic
Intervention Name(s)
comparative genomic hybridization
Intervention Type
Genetic
Intervention Name(s)
cytogenetic analysis
Intervention Type
Genetic
Intervention Name(s)
fluorescence in situ hybridization
Primary Outcome Measure Information:
Title
Frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS
Description
Estimate the frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS diagnosed in children

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary CNS malignancy consistent with primitive neuroectodermal tumor, medulloblastoma, or atypical teratoid/rhabdoid tumor Must be entered on CCG-9921, CCG-9931, CCG-A9961, CCG-99703 or other front-line studies developed from CCG-90024 or CCG-90025 Retrospective specimens also obtained from CCG-921, CCG-923, CCG-9892, CCG-9921, and CCG-9931 PATIENT CHARACTERISTICS: Age: Under 21 Performance status: See Disease Characteristics Life expectancy: See Disease Characteristics Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: See Disease Characteristics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy Not specified Radiotherapy No prior radiotherapy Surgery Not specified
Study Population Description
Children with primitive neuroectodermal tumors / medulloblastoma (PNET/Mb).
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaclyn A. Biegel, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801-1428
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048-1865
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Santa Barbara Cottage Children's Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Children's Hospital Center for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-2875
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Advocate Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1174
Country
United States
Facility Name
Swedish-American Regional Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104-2315
Country
United States
Facility Name
Simmons Cooper Cancer Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9677
Country
United States
Facility Name
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-5381
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota - St. Paul
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102-2392
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-2306
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
Carol G. Simon Cancer Center at Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Overlook Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Dayton Children's - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Tod Children's Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-9786
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
Texas Tech University Health Sciences Center School of Medicine - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3993
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113-1100
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99210-0248
Country
United States
Facility Name
Gundersen Lutheran Center for Cancer and Blood
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Children's & Women's Hospital of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada
Facility Name
Allan Blair Cancer Centre at Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre at the University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors

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