Trial Readiness Project

In preparation for large multi-center clinical trials, a study team including the University of Chicago, University of New Mexico, Mayo Clinic, Barrow Neurological Institute, University of California San Francisco, Johns Hopkins University, and the University of Utah, aimed to establish a research infrastructure for future trials.

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The Trial Readiness project assessed potential patient cohorts across study sites. The goal was to understand the variability of clinical characteristics at baseline and to study participant screening and enrollment rates.

Furthermore, a two-year follow-up of 123 participants collected data on quality of life. Follow-up also included imaging to assess hemorrhage rates and correlate lesion activity with imaging biomarkers. Those biomarkers measure lesional iron content and permeability. The team validated the reproducibility and reliability of those imaging biomarkers at multiple institutions.

For more information, view this informative WEBINAR delivered by Dr. Issam Awad.

A summary of the study and results can be found on CLINICALTRIALS.GOV.

Publications resulting from this study:

Trial Readiness of Cavernous Malformations With Symptomatic Hemorrhage, Part I: Event Rates and Clinical Outcome

Trial Readiness of Cavernous Malformations With Symptomatic Hemorrhage, Part II: Biomarkers and Trial Modeling

Baseline Characteristics of Patients With Cavernous Angiomas With Symptomatic Hemorrhage in Multisite Trial Readiness Project

Trial Readiness in Cavernous Angiomas With Symptomatic Hemorrhage (CASH)

 

Reviewed 4.23.25

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