Brain TumorsNCT00003096
Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors
An observational study of Brain Tumors and Central Nervous System Tumors, run by Children's Oncology Group at 61 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Brain Tumors, Central Nervous System Tumors
- What is being tested?
- DNA ploidy analysis, comparative genomic hybridization and cytogenetic analysis
- How many people
- 88 participants
- Where
- 61 sitesin 3 countries
- Study dates
- Dec 1996to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with primitive neuroectodermal tumors / medulloblastoma (PNET/Mb).
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
Trial locations and contacts
61 sites in 3 countries.
61 sites in 3 countries
United States56 sites
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, 79106
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, 30322
Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, 80045
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-5000
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205-2696
Dayton Children's - Dayton
Dayton, Ohio, 45404-1815
Blank Children's Hospital
Des Moines, Iowa, 50309
Southern California Permanente Medical Group
Downey, California, 90027
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, 06360-2875
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, 49503-2560
Penn State Children's Hospital
Hershey, Pennsylvania, 17033-0850
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-5381
Children's Mercy Hospital
Kansas City, Missouri, 64108
East Tennessee Children's Hospital
Knoxville, Tennessee, 37901
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, 48910
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89109-2306
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, 90801-1428
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, 90048-1865
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Kosair Children's Hospital
Louisville, Kentucky, 40232
Children's Hospital Central California
Madera, California, 93638-8762
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962
Overlook Hospital
Morristown, New Jersey, 07962
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Children's Hospital of Orange County
Orange, California, 92868
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068-1174
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-9786
Phoenix Children's Hospital
Phoenix, Arizona, 85016-7710
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
Swedish-American Regional Cancer Center
Rockford, Illinois, 61104-2315
Children's Hospitals and Clinics of Minnesota - St. Paul
Saint Paul, Minnesota, 55102-2392
Primary Children's Medical Center
Salt Lake City, Utah, 84113-1100
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229-3993
Santa Barbara Cottage Children's Hospital
Santa Barbara, California, 93105
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403-3089
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Deaconess Medical Center
Spokane, Washington, 99210-0248
Simmons Cooper Cancer Institute
Springfield, Illinois, 62794-9677
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Tod Children's Hospital
Youngstown, Ohio, 44501
Canada4 sites
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, S7N 4H4
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, V6H 3V4
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: Molecular Biology of Pediatric Brain Tumors
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.
Read the 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.
- Conditions
- Brain Tumors, Central Nervous System Tumors
- Being tested
- DNA ploidy analysis, comparative genomic hybridization, cytogenetic analysis, fluorescence in situ hybridization
- Keywords
- untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood medulloblastoma
- Medical subject headings
- Brain Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA ploidy analysisGenetic
comparative genomic hybridizationGenetic
cytogenetic analysisGenetic
fluorescence in situ hybridizationGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 1996
- Primary completionMar 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jaclyn A. Biegel, PhD, Study chair, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003096
- Sponsor's protocol ID
- B971
- Other IDs
- COG-B971, CCG-B971, CDR0000065814
- Status last verified
- Aug 2014
- First submitted
- 1 Nov 1999
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Biology of Pediatric Brain Tumors
- ClinicalTrials.gov ID
- NCT00003096
- Acronym / sponsor ID
- B971
- Conditions
- Brain Tumors, Central Nervous System Tumors
- Keywords
- untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood medulloblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1996
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with primitive neuroectodermal tumors / medulloblastoma (PNET/Mb).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA ploidy analysis | Genetic | – |
| comparative genomic hybridization | Genetic | – |
| cytogenetic analysis | Genetic | – |
| fluorescence in situ hybridization | Genetic | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclyn A. Biegel, PhD study chair
Children's Hospital of Philadelphia
61 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors and Central Nervous System Tumors, run by Children's Oncology Group at 61 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.