CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness

Brief Title

CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness

Official Title

CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

Overall enrollment rate


Condition

CCM


Study Arms / Comparison Groups

 CASH (Cavernous Angiomas with Symptomatic Hemorrhage)
Description:  The adjudicated definition of CASH (Cavernous Angiomas with Symptomatic Hemorrhage) requires diagnostic evidence of new lesional bleeding or hemorrhagic growth, in association with directly attributable symptoms.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

200

Start Date

August 15, 2018

Completion Date

November 30, 2023

Primary Completion Date

November 30, 2022

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Issam A Awad, MD, 773-834-5210, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03652181

Organization ID

U01NS104157

Secondary IDs

U01NS104157

Responsible Party

Sponsor

Study Sponsor

University of Chicago

Collaborators

 Mayo Clinic

Study Sponsor

Issam A Awad, MD, Principal Investigator, University of Chicago


Verification Date

September 2019