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NCT01417507 · ClinicalTrials.gov registry record
Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery
A clinical trial of Psychosocial Effects of Cancer and Its Treatment and Neurotoxicity, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- 82
- Enrollment target
- 20
- Study locations
NCT01417507: Completed study of Psychosocial Effects of Cancer and Its Treatment and Neurotoxicity, sponsored by Radiation Therapy Oncology Group.
NCT01417507 is a study of Psychosocial Effects of Cancer and Its Treatment and Neurotoxicity that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 82 participants, below the 421-participant average among 11 other Psychosocial Effects of Cancer and Its Treatment trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01417507, a study of Psychosocial Effects of Cancer and Its Treatment and Neurotoxicity, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- 82 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.
Primary Outcome
Each of the battery's tests will be evaluated using the 2-sample t-test with a 2-sided significance level of 0.05 to determine if there is a clinically meaningful difference in the average change of NCF score from baseline to the time of radiologic tumor progression or up to 5 years (whichever occurs first) between radiologically progressed and non-progressed patients. In order to adjust for multiple comparisons and maintain the overall type I error of 0.05, Hochberg's procedure will be applied.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- OTHER questionnaire administration
- PROCEDURE quality-of-life assessment
- PROCEDURE cognitive assessment
- PROCEDURE magnetic resonance imaging
Study Locations (20)
Hawaii
- Queen's Medical Center - Honolulu
- University of Hawaii - Honolulu
- Hawaii Medical Center East - Honolulu
- Leeward Radiation Oncology Center - ‘Ewa Beach
Alabama
- The Kirklin Clinic at Acton Road - Birmingham
- University of Alabama at Birmingham - Birmingham
- Providence Hospital - Mobile
Arizona
- Arizona Oncology Services Foundation - Phoenix
- Arizona Oncology-Deer Valley Center - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Kentucky
- Norton Health Care Pavilion - Downtown - Louisville
- Norton Suburban Hospital - Louisville
Missouri
- Washington University School of Medicine - St Louis
- Barnes West County Hospital - St Louis
Delaware
- Christiana Care Health System-Christiana Hospital - Newark
Florida
- Florida Hospital - Orlando
Georgia
- Piedmont Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-12 |
What the finished NCT01417507 record still lists
NCT01417507 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 421-participant average among 11 other Psychosocial Effects of Cancer and Its Treatment trials with a reported enrollment target (81% lower).
The record links to 7 conditions, with Psychosocial Effects of Cancer and Its Treatment appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01417507 names 20 study sites across 11 states, led by Hawaii, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01417507 about?
NCT01417507 is a clinical study titled "Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery". This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn m...
What is the current status of trial NCT01417507?
This trial is currently completed. The enrollment target is 82 participants. The study started on 2011-10. Estimated completion is 2014-12.
What conditions does trial NCT01417507 study?
This clinical trial studies the following conditions: Psychosocial Effects of Cancer and Its Treatment, Neurotoxicity, Cognitive/Functional Effects, Adult Mixed Glioma, Seizure.
What interventions are being tested in trial NCT01417507?
The interventions under investigation include: laboratory biomarker analysis (OTHER), questionnaire administration (OTHER), quality-of-life assessment (PROCEDURE), cognitive assessment (PROCEDURE), magnetic resonance imaging (PROCEDURE).
Who is sponsoring clinical trial NCT01417507?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01417507 being conducted?
This trial has 20 study locations across Alabama, Arizona, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01417507's enrollment target sits among peer trials
82 6th of 11 higher than 6 of 11 other Psychosocial Effects of Cancer and Its Treatment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psychosocial Effects of Cancer and Its Treatment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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