Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors
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| ClinicalTrials.gov Identifier: NCT00003096 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : August 6, 2014
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Brain Tumors Central Nervous System Tumors | Genetic: DNA ploidy analysis Genetic: comparative genomic hybridization Genetic: cytogenetic analysis Genetic: fluorescence in situ hybridization |
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 Type : | Observational |
| Actual Enrollment : | 88 participants |
| Official Title: | Molecular Biology of Pediatric Brain Tumors |
| Study Start Date : | December 1996 |
| Actual Primary Completion Date : | March 2006 |
| Actual Study Completion Date : | March 2007 |
- Frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETSEstimate the frequency of specific chromosomal gains, losses and rearrangements in a series of infratentorial and supratentorial PNETS diagnosed in children
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| Ages Eligible for Study: | up to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003096
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| Study Chair: | Jaclyn A. Biegel, PhD | Children's Hospital of Philadelphia |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00003096 |
| Other Study ID Numbers: |
B971 COG-B971 ( Other Identifier: Children's Oncology Group ) CCG-B971 ( Other Identifier: Children's Cancer Group ) CDR0000065814 ( Other Identifier: Clinical Trials.gov ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | August 6, 2014 |
| Last Verified: | August 2014 |
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untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood medulloblastoma |
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Neoplasms Brain Neoplasms Nervous System Neoplasms Central Nervous System Neoplasms |
Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |