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Study of Stored Tumor Samples in Young Patients With Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00897286
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief 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.

Condition or disease
Brain and Central Nervous System Tumors

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : November 30, 2004
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026


Group/Cohort
Tumor/Tissue Sample
Tumor material collected prospectively from a clinically well characterized patient cohort



Primary Outcome Measures :
  1. Relationship between molecular abnormalities and tumor histologic and clinical characteristics [ Time Frame: 20 Years ]

Biospecimen Retention:   Samples With DNA
Fresh frozen, fresh and/or cryopreserved, fixed and cultured tumor cells collected prospectively from a clinically well characterized patient cohort.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Diagnosis of tumor outside the central nervous system.
  • Age greater than or equal to 40 years at the time of diagnosis

Information from the National Library of Medicine

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): NCT00897286


Contacts
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Contact: Tabatha E. Doyle, RN 901-595-2544 tabatha.doyle@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Tabatha E. Doyle, RN    901-595-2544    tabatha.doyle@stjude.org   
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Amar Gajjar, MD St. Jude Children's Research Hospital
Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00897286    
Other Study ID Numbers: NBTP01
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
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
Additional relevant MeSH terms:
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Ependymoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Medulloblastoma
Rhabdoid Tumor
Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Neuroectodermal Tumors, Primitive
Neoplasms, Complex and Mixed