Central Nervous System Embryonal NeoplasmNCT00010114
Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children
An observational study of Central Nervous System Embryonal Neoplasm, run by Pediatric Brain Tumor Consortium at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Central Nervous System Embryonal Neoplasm
- How many people
- 83 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2001to Mar 2003
- 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 2 years
- All sexes
- No healthy volunteers
- Child
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
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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: Gene Expression Profiling of Infant Embryonal Central Nervous System Tumors by Microarray Gene Chip Analysis: Angiogenesis, Invasion and Metastasis
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.
Read the 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.
- Keywords
- childhood central nervous system germ cell tumor, childhood choroid plexus tumor, untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood medulloblastoma, newly diagnosed childhood ependymoma
- Medical subject headings
- Choroid Plexus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genes that are expressed in metastatic vs. non-metastatic tumors
Measured: Prior to therapy
Secondary outcomes (1)
Protein expression of genes found to be expressed
Measured: Prior to therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startMar 2001
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System Embryonal NeoplasmStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Brain Tumor Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Tobey MacDonald, MD, Study chair, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010114
- Sponsor's protocol ID
- CDR0000068446
- Other IDs
- PBTC-N04
- Status last verified
- Jul 2011
- First submitted
- 2 Feb 2001
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling of Infant Embryonal Central Nervous System Tumors by Microarray Gene Chip Analysis: Angiogenesis, Invasion and Metastasis
- ClinicalTrials.gov ID
- NCT00010114
- Acronym / sponsor ID
- CDR0000068446
- Keywords
- childhood central nervous system germ cell tumor, childhood choroid plexus tumor, untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood medulloblastoma, newly diagnosed childhood ependymoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Pediatric Brain Tumor ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2001
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 6 Jun 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: 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genes that are expressed in metastatic vs. non-metastatic tumors
Time frame: Prior to therapy
1 secondary outcome
Protein expression of genes found to be expressed
Time frame: Prior to therapy
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 20 Jul 2011.
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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.
Tobey MacDonald, MD study chair
Children's National Research Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Embryonal Neoplasm, run by Pediatric Brain Tumor Consortium at 9 sites in United States.
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 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Genes that are expressed in metastatic vs. non-metastatic tumors (time frame: Prior to therapy). 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 20 Jul 2011.