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.
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
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.
- Conditions
- GLIOBLASTOMA MULTIFORME, Brain Neoplasm
- 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 group | Role | What they receive |
|---|---|---|
| Brain Tumor | Brain neoplasms, malignant |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GLIOBLASTOMA MULTIFORMEStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Marcus, PhD, Principal investigator, Washington University School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIRN (Biomedical Informatics Research Network)Resources Facilitate the Personalization of Malignant Brain Tumor
- ClinicalTrials.gov ID
- NCT01124461
- Acronym / sponsor ID
- CONDR / 09-1625
- Conditions
- GLIOBLASTOMA MULTIFORME, Brain Neoplasm
- Keywords
- Malignant Brain Tumors, Cancer of the Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2010 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Tumor | – | –Brain neoplasms, malignant |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurology clinic
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to participate in serial MR studies
- KPS < 70
- > 70 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 24111225Prior 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Marcus, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
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.