Biomarkers of CASH
Biomarkers of Cerebral Cavernous Angioma With Symptomatic Hemorrhage (CASH)
2 other identifiers
observational
1,040
1 country
4
Brief Summary
The project aims to develop prognostic and diagnostic blood tests for symptomatic brain hemorrhage in patients diagnosed with cavernous angiomas, a critical clinical challenge in a disease affecting more than a million Americans. We further examine whether blood biomarkers can replace or enhance the accuracy of advanced imaging in association with lesional bleeding. The project tests a novel integrational approach of biomarker development in a mechanistically defined cerebrovascular disease, with a clinically relevant context of use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2020
CompletedFirst Submitted
Initial submission to the registry
July 8, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedAugust 11, 2025
August 1, 2025
4.9 years
July 8, 2020
August 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Circulating Diagnostic and Prognostic Biomarkers of CASH
To test whether individual and combined levels of candidate plasma proteins and miRNAs can be associated with diagnosis of CASH (cross sectional) and can predict/prognosticate future SH (longitudinal) in CAs
5 years
Secondary Outcomes (2)
Correlation of Imaging and Plasma Biomarkers of CASH
5 years
Confounders of CASH Biomarkers
5 years
Study Arms (6)
CA (non-CASH)
Cavernous Angioma (CA) without symptomatic hemorrhage cases scheduled for evaluation by their neurology or neurosurgery teams in an inpatient or outpatient setting
CA (CASH)
Cavernous Angioma (CA) with Symptomatic Hemorrhage (SH) cases scheduled for evaluation by their neurology or neurosurgery teams in an inpatient or outpatient setting
Young with seizure
Young (\<30 years old) healthy control cohorts with seizures in the prior year
Young without seizure
Young (\<30 years old) healthy control cohorts without seizures in the prior year
Older with HMA
Older (\>50 years old) with hemorrhagic microangiopathy (HMA)
Older without HMA
Older (\>50 years old) without hemorrhagic microangiopathy (HMA)
Interventions
There is no intervention for any group in this observational study.
Eligibility Criteria
We propose to recruit human subjects at three sites, with the project approved and coordinated by the University of Chicago Medicine (UCM) central institutional review board (IRB) and endorsed by respective IRBs at the other two enrolling sites. The study involves no more than minimal risks, discussed herein. The enrolling sites include UCM where the project will be led and where the data coordinating center (DCC) is located and all plasma biomarker assays and statistical analyses are planned, the University of California at San Francisco (UCSF), and Mayo Clinic, Rochester, MN (Mayo). UCSF and Mayo are participants in imaging biomarker validations in longitudinal follow-up of cavernous angioma with symptomatic hemorrhage (CASH) subjects in the TR Project. We project enrolling 1,040 cases during 4 years to address hypotheses in 3 Specific Aims (40 cases enrolled in Specific Aim 2 are also included among the 800 subjects addressing hypotheses of Specific Aim 1).
You may qualify if:
- Clinical diagnosis of CA
- age 18 or older
- solitary or multiple
- familial or sporadic
- with or without prior symptoms
You may not qualify if:
- Prior excision of a solitary CA lesion
- prior stereotactic radiosurgery or any brain irradiation
- spinal cavernoma without brain lesion
- other brain pathology unrelated to CA (demyelinating disease, brain tumor)
- seizures or stroke unrelated to CA in the prior year
- current pregnancy or within 6 months postpartum
- reluctance to undergo venipuncture or donate blood specimen, or be called for clinical follow-up for up to one year
- homeless or incarcerated persons, or other reason a subject will be unable/unlikely to be reached for follow-up
- Aim 3:
- \< 30 years of age
- one or more seizures (with or without medical therapy) in the prior year
- \> 50 years of age
- having received an MRI of the brain with SWI (susceptibility weighted imaging) sequences for any indication in the year prior to enrollment
- No HMA on brain MRI SWI sequences
- \> 50 years of age
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- Mayo Cliniccollaborator
- University of California, San Franciscocollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- Barrow Neurological Institutecollaborator
Study Sites (4)
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
University of California, San Francisco
San Francisco, California, 94117, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Girard R, Li Y, Stadnik A, Shenkar R, Hobson N, Romanos S, Srinath A, Moore T, Lightle R, Shkoukani A, Akers A, Carroll T, Christoforidis GA, Koenig JI, Lee C, Piedad K, Greenberg SM, Kim H, Flemming KD, Ji Y, Awad IA. A Roadmap for Developing Plasma Diagnostic and Prognostic Biomarkers of Cerebral Cavernous Angioma With Symptomatic Hemorrhage (CASH). Neurosurgery. 2021 Feb 16;88(3):686-697. doi: 10.1093/neuros/nyaa478.
PMID: 33469662DERIVED
Biospecimen
plasma samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Issam Awad, MD
University of Chicago
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2020
First Posted
July 13, 2020
Study Start
May 22, 2020
Primary Completion
April 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The expression profile data will be made publicly available no later than the date of initial publication or six months after the receipt of the final sequencing data, whichever comes first.
- Access Criteria
- The expression profile data will be made publicly available.
Within the first year, we will publish the protocol paper. At the end of the 5 year study, we will publish the data dictionary along with study findings. The expression profile data will be made publicly available no later than the date of initial publication or six months after the receipt of the final sequencing data, whichever comes first.