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NCT01764529 · ClinicalTrials.gov registry record
Modifiers of Disease Severity in Cerebral Cavernous Malformations
A clinical trial of Cavernous Angioma, Familial and Cerebral Cavernous Malformations, sponsored by University of California, San Francisco.
- Active
- Registry status
- 800
- Enrollment target
- 7
- Study locations
NCT01764529: Active study of Cavernous Angioma, Familial and Cerebral Cavernous Malformations, sponsored by University of California, San Francisco.
NCT01764529 is a study of Cavernous Angioma, Familial and Cerebral Cavernous Malformations that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 800 participants. The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764529, a study of Cavernous Angioma, Familial and Cerebral Cavernous Malformations, is active but no longer recruiting, sponsored by University of California, San Francisco.
- ACTIVE NOT RECRUITING
- Registry status
- 800 participants
- Enrollment target
- 7
- Study locations
Study Summary
Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. CCMs are often caused by an inherited gene mutation (alteration) in one of three CCM genes (CCM1, CCM2, or CCM3). There is a wide range of disease severity even among family members with this disease, though the natural history has not been clearly described for this particular population. This study will continue to enroll and follow participants with familial CCM to identify factors that influence CCM disease severity and progression, focusing on barriers to clinical trial preparedness. Our long-term goal is to identify measurable outcomes and robust biomarkers that will help select high-risk patients and help monitor drug response in future clinical trials. The specific goals of this study are to: * Identify factors that influence lesion progression to symptomatic hemorrhage and other outcomes, including quality of life; * Investigate the role of the gut microbiome and lesion burden in CCM disease, and * Identify blood biomarkers predictive of CCM disease severity and progression for clinical trials.
Primary Outcome
The number of lesions (or cavernous angiomas) located in the brain will be counted by a neuroradiologist and by an automated algorithm developed as part of this project.
Conditions Studied
Study Locations (7)
Arizona
- Barrow Neurological Institute - Phoenix
California
- University of California, San Francisco - San Francisco
Illinois
- University of Chicago, Medicine and Biological Sciences - Chicago
Massachusetts
- Boston Children's Hospital - Boston
New Mexico
- University of New Mexico Health Sciences Center - Albuquerque
Ohio
- Cincinnati Children's Hospital, Division of Pediatric Neurosurgery, Cerebrovascular Program - Cincinnati
Virginia
- Alliance to Cure Cavernous Malformation - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2010-04-27 |
| Est. Completion | 2025-06 |
What the registry record for NCT01764529 still lists
NCT01764529 is an observational study that tracks outcomes without assigning an intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap.
The record links to 3 conditions, with Cavernous Angioma, Familial appearing as the primary indexed condition, and to 0 interventions.
NCT01764529 lists 7 locations in 7 states (Arizona, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT01764529 about?
NCT01764529 is a clinical study titled "Modifiers of Disease Severity in Cerebral Cavernous Malformations". Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. CCMs are often caused by an inherited gene mutation (alteration) in one of three CCM genes (CCM1, CCM2, or CCM3). There is a wide range of...
What is the current status of trial NCT01764529?
This trial is currently active not recruiting. The enrollment target is 800 participants. The study started on 2010-04-27. Estimated completion is 2025-06.
What conditions does trial NCT01764529 study?
This clinical trial studies the following conditions: Cavernous Angioma, Familial, Cerebral Cavernous Malformations, Cerebral Cavernous Hemangioma.
Who is sponsoring clinical trial NCT01764529?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01764529 being conducted?
This trial has 7 study locations across Arizona, California, Illinois, Massachusetts, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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