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CompletedNCT01124461CONDRUpdated May 11, 2018

BIRN (Biomedical Informatics Research Network) Resources Facilitate the Personalization of Malignant Brain Tumor

An observational study in GLIOBLASTOMA MULTIFORME and Brain Neoplasm, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-05-11.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
112
Ages
18 Years to 70 Years
Sex
All
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Study summary

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.

Read the detailed description

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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Conditions studied

  • GLIOBLASTOMA MULTIFORME
  • Brain Neoplasm

Keywords

  • Malignant Brain Tumors
  • Cancer of the Brain
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In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 112 is above the median of 60 across 188 observational studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Neurology clinic

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

Exclusion Criteria:

  • Inability to participate in serial MR studies
  • KPS \< 70
  • > 70 years of age
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
112 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Brain Tumor

    Brain neoplasms, malignant

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Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
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References and documents

Publications

  • Prior FW, Fouke SJ, Benzinger T, Boyd A, Chicoine M, Cholleti S, Kelsey M, Keogh B, Kim L, Milchenko M, Politte DG, Tyree S, Weinberger K, Marcus D. Predicting a multi-parametric probability map of active tumor extent using random forests. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6478-81. doi: 10.1109/EMBC.2013.6611038. PubMed 24111225 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01124461
Lead sponsor
Washington University School of Medicine
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Sponsor
First posted
May 17, 2010
Start date
Jan 2010
Primary completion
Nov 2017
Completion
Nov 2017
Last update
May 11, 2018

Study contacts

Daniel Marcus, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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