Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
38 participants
OBSERVATIONAL
2001-03-31
2004-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Genetic study to understand how genes may be involved in the development of brain tumors in young children.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children
NCT00010114
Neurofibromatosis Type 1 Brain Tumor Genetic Risk
NCT01707836
Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology
NCT00315263
Genetics of Familial Testicular Cancer
NCT00342537
Genetic Analysis of Familial Melanoma
NCT00339404
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the frequency and type of deletions and mutations of the INI1 gene in infants with embryonal central nervous system tumors.
* Compare the gene expression profiles in infants with atypical teratoid/rhabdoid tumors vs medulloblastoma or primitive neuroectodermal tumor.
OUTLINE: This is a multicenter study.
Tumor samples are analyzed by fluorescence in situ hybridization (FISH) for deletions of INI1 gene in chromosome band 22q11.2. Tumors without demonstration of deletions of INI1 gene by FISH are examined by polymerase chain reaction (PCR)-based microsatellite analysis for loss of heterozygosity using markers that map to 22q11.2.
DNA from tumor tissue is analyzed for mutations in the exons of the INI1 gene. Isolated matched normal DNA may be analyzed for identification of germline mutations. Parental DNA may be analyzed to identify inherited germline mutations of the INI1 gene.
The patient's physician may receive the results of the genetic testing. The results do not influence the type or duration of treatment.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 25 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically confirmed primary intracranial central nervous system tumor
* Medulloblastoma
* Primitive neuroectodermal tumor
* Atypical teratoid/rhabdoid tumor
* Choroid plexus carcinoma
* Potential enrollment on PBTC-001 therapeutic protocol
PATIENT CHARACTERISTICS:
Age:
* Under 3
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Prior steroids allowed
Radiotherapy:
* No prior radiotherapy
Surgery:
* Not specified
Other:
* No concurrent investigational agents
3 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Pediatric Brain Tumor Consortium
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pediatric Brain Tumor Consortium
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jaclyn A. Biegel, PhD
Role: STUDY_CHAIR
Children's Hospital of Philadelphia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Texas Children's Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pomeroy SL, Tamayo P, Gaasenbeek M, Sturla LM, Angelo M, McLaughlin ME, Kim JY, Goumnerova LC, Black PM, Lau C, Allen JC, Zagzag D, Olson JM, Curran T, Wetmore C, Biegel JA, Poggio T, Mukherjee S, Rifkin R, Califano A, Stolovitzky G, Louis DN, Mesirov JP, Lander ES, Golub TR. Prediction of central nervous system embryonal tumour outcome based on gene expression. Nature. 2002 Jan 24;415(6870):436-42. doi: 10.1038/415436a.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PBTC-N03
Identifier Type: -
Identifier Source: secondary_id
CDR0000068445
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.