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GLIOBLASTOMA MULTIFORMECONDRNCT01124461

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

An observational study of GLIOBLASTOMA MULTIFORME and Brain Neoplasm, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
GLIOBLASTOMA MULTIFORME, Brain Neoplasm
How many people
112 participants
Where
1 siteUnited States
Study dates
Jan 2010to Nov 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Neurology clinic

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Keywords
Malignant Brain Tumors, Cancer of the Brain
Medical subject headings
Glioblastoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01124461
Study groupRoleWhat they receive
Brain TumorBrain neoplasms, malignant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01124461
Sponsor's protocol ID
09-1625
Other IDs
1R01NS066905-01
Acronym
CONDR
Status last verified
May 2018
First submitted
13 May 2010
Last updated
11 May 2018
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

An observational study of GLIOBLASTOMA MULTIFORME and Brain Neoplasm, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01124461, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.

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