BIRN (Biomedical Informatics Research Network) Resources Facilitate the Personalization of Malignant Brain Tumor (CONDR)
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|ClinicalTrials.gov Identifier: NCT01124461|
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : May 10, 2018
|Condition or disease|
|GLIOBLASTOMA MULTIFORME Brain Neoplasm|
Glioblastoma (GBM) is the most common primary malignant neoplasm of the adult brain. Even after multimodal therapy, treatment outcomes remain poor, with a median survival of approximately one year. A central challenge facing investigators in the modern era is how to resolve the heterogeneity inherent in GBM pathology using technology and how to identify individual genetic or molecular markers that indicate how treatment can be individualized to improve outcomes with an emphasis on using this heterogeneity to improve patient care. With advances in imaging and the potential for genetic sequence analysis, increasingly clinicians and researchers have focused on specific clinical, imaging, and genetic biomarkers to allow the personalization of brain tumor treatment in an attempt to improve the limitations we have faced in extending patient survival from this devastating disease. Specific methodologies have been developed to allow genetic microarray analysis of patient's tumor tissue, and this type of research is ongoing at one of our participating institutions, Swedish Medical Center. In addition, centers such as Washington University School of Medicine in St. Louis, Missouri have extensive experience pursuing advanced imaging biomarkers and their applications to clinical neuro-oncology research.
Of importance, however, although clinicians and researchers have come to recognize that in-vivo imaging technologies may have as much if not more relevance than genetic biomarkers in the personalization of brain tumor treatment, clinical trials attempting to validate these biomarkers and correlate them with particular outcomes have been limited by a lack of technology infrastructure that would allow multi-site image acquisition, processing, data analysis, subsequent correlation with clinical and genetic data, and ultimately sharing of anonymized data with other researchers from a central archiving site. BIRN infrastructure will integrate neuroimaging, genetic microarray, and clinical data with a focus on integrating imaging biomarkers into prospective clinical research in patients with malignant brain tumors.
In this project, a consortium of neuro-oncology research centers will be federated to obtain a unified set of clinical, genetic, and imaging data. In the initial phase, 100 patients with malignant brain tumors at two participating sites will be studied. Our ultimate goal will be to use the developed protocols and informatics infrastructure to expand the consortium to include a large number neuro-oncology clinical sites suitable for executing large scale clinical trials that will facilitate the generation of data to identify which imaging biomarkers are relevant for the personalization of brain tumor treatment and ultimately improvement of outcomes for patients with this devastating disease.
|Study Type :||Observational|
|Actual Enrollment :||112 participants|
|Official Title:||BIRN (Biomedical Informatics Research Network)Resources Facilitate the Personalization of Malignant Brain Tumor|
|Actual Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Brain neoplasms, malignant
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): NCT01124461
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Daniel Marcus, PhD||Washington University School of Medicine|