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Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children
This study has been completed.
Sponsor:
Pediatric Brain Tumor Consortium
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Pediatric Brain Tumor Consortium
ClinicalTrials.gov Identifier:
NCT00010114
First received: February 2, 2001
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.
PURPOSE: Genetic study to learn more about genes involved in the development of central nervous system tumors in young children.
| Condition |
|---|
| Central Nervous System Embryonal Neoplasm |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Gene Expression Profiling of Infant Embryonal Central Nervous System Tumors by Microarray Gene Chip Analysis: Angiogenesis, Invasion and Metastasis |
Resource links provided by NLM:
MedlinePlus related topics:
Genes and Gene Therapy
Genetic and Rare Diseases Information Center resources:
Ependymoma
Neuroepithelioma
Medulloblastoma
Medulloblastoma, Childhood
Supratentorial Primitive Neuroectodermal Tumor
Supratentorial Primitive Neuroectodermal Tumors, Childhood
U.S. FDA Resources
Further study details as provided by Pediatric Brain Tumor Consortium:
Primary Outcome Measures:
- Genes that are expressed in metastatic vs. non-metastatic tumors [ Time Frame: Prior to therapy ]
Secondary Outcome Measures:
- Protein expression of genes found to be expressed [ Time Frame: Prior to therapy ]
| Enrollment: | 83 |
| Study Start Date: | March 2001 |
| Study Completion Date: | March 2003 |
| Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Newly diagnosed embryonal tumors
The participants in this study are infants (< 3 years of age) with newly diagnosed medulloblastoma, primitive neuroectodermal tumor, or other embryonal tumor, atypical teratoid/rhabdoid tumor, intracranial germ cell tumor, or choroid plexus carcinoma who have received no prior therapy with the exception of steroids and have consented to allow research studies on banked tissue specimens
|
Detailed Description:
OBJECTIVES:
- Identify known genes that have significantly different levels of expression, using microarray gene chip analysis, in infants with newly diagnosed metastatic vs non-metastatic embryonal central nervous system tumors.
- Determine the protein expression of genes identified by microarray analysis that are involved in cellular functions that regulate angiogenesis, invasion, or metastasis in this patient population.
- Determine the quantity of gene expression of the confirmed translationally expressed genes using semi-quantitative polymerase chain reaction.
OUTLINE: This is a multicenter study.
Tumor samples are analyzed using microarray gene chip analysis. Differentially expressed genes are evaluated for protein expression by standard immunohistochemistry and/or Western blot analysis, and gene expression is further quantified by semi-quantitative polymerase chain reaction.
PROJECTED ACCRUAL: Approximately 80-100 patients (20-25 with metastatic disease and 60-75 with non-metastatic disease) will be accrued for this study within 4-5 years.
Eligibility| Ages Eligible for Study: | up to 2 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The participants in this study are infants (< 3 years of age) with newly diagnosed medulloblastoma, primitive neuroectodermal tumor, or other embryonal tumor, atypical teratoid/rhabdoid tumor, intracranial germ cell tumor, or choroid plexus carcinoma who have received no prior therapy with the exception of steroids and have consented to allow research studies on banked tissue specimens
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed, newly diagnosed, primary intracranial embryonal central nervous system tumor
- Medulloblastoma
- Primitive neuroectodermal tumor
- Medulloepithelioma
- Ependymoblastoma
- Neuroblastoma
- Pineoblastoma
- Atypical teratoid/rhabdoid tumor
- Intracranial germ cell tumor
- Choroid plexus carcinoma
- M positive ependymoma
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010114
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010114
Locations
| United States, California | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
Investigators
| Study Chair: | Tobey MacDonald, MD | Children's Research Institute |
More Information
| Responsible Party: | James M. Boyett, Executive Director Operations and Biostatistics Center, Pediatric Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00010114 History of Changes |
| Other Study ID Numbers: |
CDR0000068446 PBTC-N04 |
| Study First Received: | February 2, 2001 |
| Last Updated: | July 19, 2011 |
Keywords provided by Pediatric Brain Tumor Consortium:
|
childhood central nervous system germ cell tumor childhood choroid plexus tumor untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood medulloblastoma newly diagnosed childhood ependymoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Site |
Neoplasms Nervous System Diseases Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on July 21, 2017