CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness



Status:Recruiting
Conditions:Women's Studies, Hematology
Therapuetic Areas:Hematology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:August 15, 2018
End Date:November 30, 2022
Contact:Kristina Piedad, BSN, RN
Email:Kristina.Piedad@uchospitals.edu
Phone:773-834-5210

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Brain Cavernous Angiomas with Symptomatic Hemorrhage (CASH) are rare, but they exact a heavy
burden of neurologic disability from recurrent bleeding, for which there is no proven
therapy. This trial readiness project aims to address current critical obstacles in
identifying cases at multiple sites, characterizing their relevant features, and measuring
their outcome. The timing cannot be more opportune, with therapeutic targets already
identified, exceptional collaboration among researchers and with the patient community, and
several drugs ready to benefit from a track to clinical testing in the next five years.

The Trial Readiness grant mechanism, funded by NINDS, proposes to address knowledge gaps and
establish a research network as infrastructure for future research. This project includes an
observational cohort study to assess (1) the feasibility of screening, enrollment rates,
baseline disease categorization and follow-up of CASH using common data elements at multiple
sites, (2) the reliability of imaging biomarkers including quantitative susceptibility
mapping and permeability measures which have been shown to correlate with lesion activity,
and (3) the rates of recurrent hemorrhage and change in functional status and biomarker
measurements during prospective follow-up.

Inclusion Criteria

1. 18 years of age and older

2. Diagnosed with a brain CA (single or multiple)

3. Had a SH within the past year (with demonstrated new lesional bleeding or hemorrhagic
growth on diagnostic studies AND attributable new symptoms)

4. No prior treatment of the symptomatic lesion (after neurosurgical consultation).

Exclusion Criteria

1. Spinal CA as source of SH

2. Prior brain irradiation

3. Cases where verification of SH with clinical and imaging review cannot be accomplished

To be eligible for Aims 2 and 3, CASH cases enrolled in Aim 1 will be further excluded from
follow-up and baseline validation (FUBV) for the following reasons:

1. Contraindication for administration of contrast agent or otherwise unwilling or unable
to undergo research MRI studies

2. Pregnant or breastfeeding women

3. Homeless or incarcerated persons, or other reason a subject will be unable/unlikely to
return for follow-up visits
We found this trial at
1
site
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Issam A Awad, MD
Phone: 773-834-5210
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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