View Clinical Trial (Medical Research Study)
BIRN (Biomedical Informatics Research Network)Resources Facilitate the Personalization of Malignant Brain Tumor
| City: |
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St. Louis |
| State: |
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Missouri |
| Zip Code: |
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63110 |
| Conditions: |
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GLIOBLASTOMA MULTIFORME - Brain Neoplasm |
| Purpose: |
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The goal of this study is to create a comprehensive database of Magnetic Resonance Imaging
(MRI) and of pathology for patients with brain tumors. Both standard, advanced, and research
MRI components may be included, these will be analyzed in comparison with pathology results
if/when a biopsy is obtained, and also used to predict/evaluate responses to therapy. This
study will create a database of de-identified MRI images which include these techniques so
that brain tumors can be studied over time (longitudinally) in an organized manner.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Patients will be enrolled in this clinical trial pre-operatively anticipating a
surgical resection with anticipation that the patient carries a likely diagnosis of
malignant glioma.
- Patients will only be enrolled if it is anticipated that the resection will give
significant tissue for subsequent genetic analysis (1 cm of tumor tissue)
- If patients at surgery are found to carry an alternative tissue diagnosis, the
patient's preoperative imaging, clinical, and pathological information will be
uploaded into the database, but the patient will not be counted as one of the
participants
- Ability to undergo serial MR studies
- Enrollment KPS > 70
- Anticipation that surgery will allow subtotal resection or gross total resection,
facilitating removal of tissue specimens for genomic analysis.
Exclusion Criteria:
- Inability to participate in serial MR studies
- KPS < 70
- > 70 years of age
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| NCT ID: |
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NCT01124461 |
| Primary Contact: |
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Principal Investigator
Daniel Marcus, PhD
Washington University School of Medicine
Anna Carlson, RN
Phone: 314-747-8273
Email: carlsona@mir.wustl.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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St. Louis, Missouri 63110
United States
Anna Carlson, RN
Phone: 314-747-8273
Email: carlsona@mir.wustl.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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