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Trial record 10 of 11 for:    Cavernous Malformation

CASH (Cavernous Angiomas With Symptomatic Hemorrhage) Trial Readiness

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ClinicalTrials.gov Identifier: NCT03652181
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of Chicago

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
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.

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


Group/Cohort
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.



Primary Outcome Measures :
  1. Overall enrollment rate [ Time Frame: Years 2-5 ]
    Assessment of enrollment rates of CASH



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Brain Cavernous Angiomas with Symptomatic Hemmhorage (CASH) that have occurred within the last year.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652181


Contacts
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Contact: Kristina Piedad, BSN, RN 773-834-5210 Kristina.Piedad@uchospitals.edu
Contact: Agnieszka Stadnik, MS 773-702-8996 astadnik@surgery.bsd.uchicago.edu

Locations
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United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Kristina Piedad, BSN, RN    773-834-5210    Kristina.Piedad@uchospitals.edu   
Contact: Agnieszka Stadnik, MS    773-702-8996    astadnik@surgery.bsd.uchicago.edu   
Principal Investigator: Issam A Awad, MD         
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
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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

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03652181     History of Changes
Other Study ID Numbers: U01NS104157 ( U.S. NIH Grant/Contract )
U01NS104157 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study Protocol has been published in Neurosurgery
Supporting Materials: Study Protocol

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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:
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Congenital Abnormalities
Hemangioma, Cavernous, Central Nervous System
Hemangioma, Cavernous
Central Nervous System Vascular Malformations
Nervous System Malformations
Vascular Malformations
Cardiovascular Abnormalities
Jaw Abnormalities
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic System Abnormalities
Hemorrhage
Hemangioma
Intellectual Disability
Micrognathism
Pathologic Processes
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Nervous System Diseases
Cardiovascular Diseases
Hemostatic Disorders
Vascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurodevelopmental Disorders