Study of Stored Tumor Samples in Young Patients With Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A - 39 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00897286
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	St. Jude Children's Research Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Amar Gajjar, MD
Principal Investigator Affiliation	St. Jude Children's Research Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain and Central Nervous System Tumors
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: Tumor/Tissue Sample

Tumor material collected prospectively from a clinically well characterized patient cohort

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Recruiting

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Site Contact

Tabatha E. Doyle, RN

[email protected]

901-595-2544