BIRN (Biomedical Informatics Research Network) Resources Facilitate the Personalization of Malignant Brain Tumor (CONDR)
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01124461 |
Recruitment Status
: Unknown
Verified March 2011 by Washington University School of Medicine.
Recruitment status was: Recruiting
First Posted
: May 17, 2010
Last Update Posted
: March 4, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | BIRN (Biomedical Informatics Research Network)Resources Facilitate the Personalization of Malignant Brain Tumor |
Study Start Date : | January 2010 |
Estimated Study Completion Date : | January 2015 |

Group/Cohort |
---|
Brain Tumor
Brain neoplasms, malignant
|

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
Contact: Anna Carlson, RN | 314-747-8273 | carlsona@mir.wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Anna Carlson, RN 314-747-8273 carlsona@mir.wustl.edu | |
Principal Investigator: Daniel Marcus, PhD |
Principal Investigator: | Daniel Marcus, PhD | Washington University School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Daniel Marcus/ Research Assistant Professor of Rad, Washington University-RADIOLOGY RADIATION-SCIENCES-SCHOOL OF MEDICINE |
ClinicalTrials.gov Identifier: | NCT01124461 History of Changes |
Other Study ID Numbers: |
09-1625 1R01NS066905-01 ( U.S. NIH Grant/Contract ) |
First Posted: | May 17, 2010 Key Record Dates |
Last Update Posted: | March 4, 2011 |
Last Verified: | March 2011 |
Keywords provided by Washington University School of Medicine:
Malignant Brain Tumors Cancer of the Brain |
Additional relevant MeSH terms:
Glioblastoma Brain Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |