CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness

• Sponsor: University of Chicago (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03652181
• Collaborator: Mayo Clinic (Other), Johns Hopkins University (Other), University of California, San Francisco (Other), National Institute of Neurological Disorders and Stroke (NINDS) (NIH), University of Utah (Other), University of New Mexico (Other), Barrow Neurological Institute (Other)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 63.5
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CCM; Cavernoma; Cerebral Cavernous Malformation; Cerebral Cavernous Malformations 1; Cerebral Cavernous Malformations 2; Cerebral Cavernous Malformations 3; Cavernous Angioma

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness
• Actual Study Start Date: Aug 15, 2018
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
CASH (Cavernous Angiomas with Symptomatic Hemorrhage) 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.

Outcome Measures

Primary Outcome Measures

1. Overall enrollment rate [Years 2-5]

   Assessment of enrollment rates of CASH

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. Subject is able to provide informed consent

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

4. Prior or planned treatment of the symptomatic lesion (after neurosurgical consultation)

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago Medical Center	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• Mayo Clinic
• Johns Hopkins University
• University of California, San Francisco
• National Institute of Neurological Disorders and Stroke (NINDS)
• University of Utah
• University of New Mexico
• Barrow Neurological Institute

Investigators

• Principal Investigator: Issam A Awad, MD, University of Chicago
• Principal Investigator: Daniel Hanley, MD, Johns Hopkins University
• Principal Investigator: Kelly Flemming, MD, Mayo Clinic
• Principal Investigator: Helen Kim, MPH, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT03652181
• Other Study ID Numbers: U01NS104157; U01NS104157
• First Posted: Aug 29, 2018
• Last Update Posted: Dec 22, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Chicago: CCM (Cerebral Cavernous Malformations); Dynamic Contrast Enhanced Quantitative Perfusion (DCEQP); Quantitative Susceptibility Mapping (QSM); Cerebral Cavernous Malformation; Cavernoma; Cavernous Angioma
• Additional relevant MeSH terms: Hemangioma, Cavernous, Central Nervous System; Hemangioma; Hemangioma, Cavernous; Congenital Abnormalities; Hemorrhage

Study Results

No Results Posted as of Dec 22, 2021