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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00897286
Other study ID # NBTP01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2004
Est. completion date February 2026

Study information

Verified date August 2023
Source St. Jude Children's Research Hospital
Contact Tabatha E. Doyle, RN
Phone 901-595-2544
Email tabatha.doyle@stjude.org
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date February 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 39 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (1)

Lead Sponsor Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relationship between molecular abnormalities and tumor histologic and clinical characteristics 20 Years
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