Brain and Central Nervous System TumorsNCT00897286
Study of Stored Tumor Samples in Young Patients With Brain Tumors
An observational study of Brain and Central Nervous System Tumors, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This laboratory study is looking at stored tumor samples in young patients with brain tumors. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages Up to 39 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2004to 25 Sep 2025
- 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 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will all brain tumor types will be included with a focus on medulloblastoma, HGNET, CNS embryonal tumors, gliomas, ependymoma, CPC and ATRT tumors. All studies will be conducted using tumor material collected prospectively from a clinically well characterized patient cohort.
Who may be able to join
- Tumor may be primary, progressive or recurrent CNS tumor including brain and/or spine. All tumor types will be included with a focus on medulloblastoma, HGNET, CNS embryonal tumors, gliomas, ependymoma, CPC and ATRT tumors. Low grade gliomas are currently very challenging to culture and implant but if techniques mature these will also be included. Although rare, patients with ATRT may present with a primary renal and CNS tumor. In these instances samples will be collected from both the kidney and CNS tumor for analysis if available.
- Tumor may be collected at surgery prior to histologic confirmation
- Age less than 40 years at the time of initial diagnosis.
- Enrollment in the current version of the institution's banking protocol
Who cannot join
- Diagnosis of tumor outside the central nervous system.
- Age greater than or equal to 40 years at the time of diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Molecular and Histopathologic Characterization of Atypical Teratoid Rhabdoid Tumors, Choroid Plexus Carcinomas, Ependymomas, Medulloblastoma HGNET, CNS Embryonal Tumors and Gliomas of the Pediatric CNS
This laboratory study is looking at stored tumor samples in young patients with brain tumors. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
Read the detailed description
The overall objective of this non-therapeutic protocol is to develop and molecularly characterize patient-derived orthotopic xenografts (PDOXs), organoids and in vitro models derived from medulloblastomas, High Grade Neuroepithelial Tumors (HGNET), CNS embryonal tumors, Atypical Teratoid Rhabdoid Tumors (ATRTs), Choroid Plexus Carcinomas (CPCs), ependymomas, and gliomas. The investigators will characterize the genome-wide mutation, expression and epigenetic signatures of these models and compare them with the primary tumors from which they were derived, thus creating a well-characterized and invaluable resource for research on these rare and deadly pediatric brain tumors. This will also provide important insights into intratumoral heterogeneity, and molecular abnormalities that may influence the selective pressures driving evolution, and tumor growth as in PDOXs, organoids or in vitro cultures and define the relationship between these abnormalities and tumor histologic and clinical characteristics. This objective will be achieved by applying state-of-the-art DNA, RNA and epigenome analysis tools to the study of fresh frozen and/or cryopreserved, fixed and cultured tumor cells, PDOXs and organoids. The establishment of patient-derived orthotopic xenografts, organoids and cell cultures from each tumor sample will also allow for in vitro and in vivo analysis of tumor cell growth, signaling and therapeutic response.
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood atypical teratoid/rhabdoid tumor, childhood choroid plexus tumor, childhood medulloblastoma, recurrent childhood medulloblastoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent childhood ependymoma, recurrent childhood supratentorial primitive neuroectodermal tumor, untreated childhood supratentorial primitive neuroectodermal tumor, gliomas
- Medical subject headings
- Central Nervous System Neoplasms, Rhabdoid Tumor, Choroid Plexus Neoplasms, Medulloblastoma, Familial ependymoma, Glioma
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 |
|---|---|---|
| Tumor/Tissue Sample | Tumor material collected prospectively from a clinically well characterized patient cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between molecular abnormalities and tumor histologic and clinical characteristics
Measured: 20 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start30 Nov 2004
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Why it stopped: New Protocol that replaces the current study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amar Gajjar, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897286
- Sponsor's protocol ID
- NBTP01
- Status last verified
- Oct 2025
- First submitted
- 9 May 2009
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Histopathologic Characterization of Atypical Teratoid Rhabdoid Tumors, Choroid Plexus Carcinomas, Ependymomas, Medulloblastoma HGNET, CNS Embryonal Tumors and Gliomas of the Pediatric CNS
- ClinicalTrials.gov ID
- NCT00897286
- Acronym / sponsor ID
- NBTP01
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- childhood atypical teratoid/rhabdoid tumor, childhood choroid plexus tumor, childhood medulloblastoma, recurrent childhood medulloblastoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent childhood ependymoma, recurrent childhood supratentorial primitive neuroectodermal tumor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: New Protocol that replaces the current study
- Enrolment
- 139 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 30 Nov 2004 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 12 May 2009 (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.
This laboratory study is looking at stored tumor samples in young patients with brain tumors. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
Detailed description
The overall objective of this non-therapeutic protocol is to develop and molecularly characterize patient-derived orthotopic xenografts (PDOXs), organoids and in vitro models derived from medulloblastomas, High Grade Neuroepithelial Tumors (HGNET), CNS embryonal tumors, Atypical Teratoid Rhabdoid Tumors (ATRTs), Choroid Plexus Carcinomas (CPCs), ependymomas, and gliomas. The investigators will characterize the genome-wide mutation, expression and epigenetic signatures of these models and compare them with the primary tumors from which they were derived, thus creating a well-characterized and invaluable resource for research on these rare and deadly pediatric brain tumors. This will also provide important insights into intratumoral heterogeneity, and molecular abnormalities that may influence the selective pressures driving evolution, and tumor growth as in PDOXs, organoids or in vitro cultures and define the relationship between these abnormalities and tumor histologic and clinical characteristics. This objective will be achieved by applying state-of-the-art DNA, RNA and epigenome analysis tools to the study of fresh frozen and/or cryopreserved, fixed and cultured tumor cells, PDOXs and organoids. The establishment of patient-derived orthotopic xenografts, organoids and cell cultures from each tumor sample will also allow for in vitro and in vivo analysis of tumor cell growth, signaling and therapeutic response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor/Tissue Sample | – | –Tumor material collected prospectively from a clinically well characterized patient cohort |
Who may qualify
- Ages
- Up to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will all brain tumor types will be included with a focus on medulloblastoma, HGNET, CNS embryonal tumors, gliomas, ependymoma, CPC and ATRT tumors. All studies will be conducted using tumor material collected prospectively from a clinically well characterized patient cohort.
Key inclusion criteria (4 listed)
- Tumor may be primary, progressive or recurrent CNS tumor including brain and/or spine. All tumor types will be included with a focus on medulloblastoma, HGNET, CNS embryonal tumors, gliomas, ependymoma, CPC and ATRT tumors. Low grade gliomas are currently very challenging to culture and implant but if techniques mature these will also be included. Although rare, patients with ATRT may present with a primary renal and CNS tumor. In these instances samples will be collected from both the kidney and CNS tumor for analysis if available.
- Tumor may be collected at surgery prior to histologic confirmation
- Age less than 40 years at the time of initial diagnosis.
- Enrollment in the current version of the institution's banking protocol
Key exclusion criteria (2 listed)
- Diagnosis of tumor outside the central nervous system.
- Age greater than or equal to 40 years at the time of diagnosis
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
Relationship between molecular abnormalities and tumor histologic and clinical characteristics
Time frame: 20 Years
Results and safety
The study was stopped early (reason given: New Protocol that replaces the current study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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.
Amar Gajjar, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors, run by St. Jude Children's Research Hospital at 1 site 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: New Protocol that replaces the current study). Results are not available in the source record.
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?
Relationship between molecular abnormalities and tumor histologic and clinical characteristics (time frame: 20 Years). 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 Oct 2025.