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Trial record 1 of 3 for:    "Cerebral cavernous malformation"
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Modifiers of Disease Severity in Cerebral Cavernous Malformations

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of New Mexico
Sponsor:
Collaborators:
University of California, San Francisco
Information provided by (Responsible Party):
Leslie Morrison, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01764529
First received: January 7, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In the Hispanic population of the southwest, CCMs are often caused by an inherited gene mutation (alteration), termed the common Hispanic mutation (CCM1-CHM). There is a wide range of disease severity even among family members with this disease, though the natural history has not been clearly described for this particular population.

This study will examine factors that influence disease severity through the collection of blood samples, detailed medical histories, physical and neurological exam, and magnetic resonance imaging (MRI) of the brain. The specific goals of this study are to:

  1. establish a registry/database of familial CCM cases with detailed clinical data,
  2. perform genetic testing on participant blood samples to identify other genes that may influence the development and hemorrhage of CCM lesions, and
  3. determine lesion growth during the study.

Condition Intervention
Cavernous Angioma, Familial
Cerebral Cavernous Malformations
Cerebral Cavernous Hemangioma
Other: Natural history data collection

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 4 Years
Official Title: Modifiers of Disease Severity in Cerebral Cavernous Malformations

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Lesion number [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The number of lesions (or cavernous angiomas) located in the brain will be counted by a neuroradiologist.


Secondary Outcome Measures:
  • Change in lesion number [ Time Frame: Baseline, Follow up MRI ] [ Designated as safety issue: No ]
    The number of lesions (or cavernous angiomas) counted on the baseline MRI will be compared to the number of lesions observed in the follow up study MRI. This will only be performed for the first 100 participants in the study.

  • Neurological status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The neurological status of participants will be evaluated by a neurologist.


Biospecimen Retention:   Samples With DNA

We collect and store saliva as well as whole blood for DNA and RNA extraction.


Estimated Enrollment: 500
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CCM1-CHM Participants
All individuals in the study have CCM1-CHM and will participate in the natural history data collection.
Other: Natural history data collection
Collection of detailed medical history, brain MRI, and neurological and physical examination.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population includes individuals who carry the cerebral cavernous malformation-common Hispanic mutation (CCM1-CHM). We are enrolling individuals who are symptomatic as well as those individuals with no symptoms. Although this disease is common in New Mexico, we are interested in enrolling individuals worldwide if they have CCM1-CHM.

Criteria

Inclusion Criteria:

  • Diagnosis of cerebral cavernous malformations-common Hispanic mutation.

Exclusion Criteria:

  • Incarceration
  • Unable to pass MRI safety screening (pregnant females, claustrophobic, or those with certain metallic items implanted in their bodies)
  • Individuals who are unable to tolerate MRI without sedation, which refers mailed to children < 6 years old.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764529

Contacts
Contact: Beth Baca, MSW 505-272-3194 babaca@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Health Sciences Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Beth Baca, MSW    505-272-3194    babaca@salud.unm.edu   
Principal Investigator: Leslie Morrison, MD         
Sub-Investigator: Blaine Hart, MD         
Sponsors and Collaborators
University of New Mexico
University of California, San Francisco
Investigators
Principal Investigator: Leslie Morrison, MD University of New Mexico
Principal Investigator: Blaine Hart, MD University of New Mexico
  More Information

Additional Information:
No publications provided

Responsible Party: Leslie Morrison, Vice Chancellor for Academic Affairs, University of New Mexico
ClinicalTrials.gov Identifier: NCT01764529     History of Changes
Other Study ID Numbers: BVMC 6201, U54NS065705
Study First Received: January 7, 2013
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Hispanic

Additional relevant MeSH terms:
Congenital Abnormalities
Hemangioma
Hemangioma, Cavernous
Hemangioma, Cavernous, Central Nervous System
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Vascular Malformations
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Nervous System Diseases
Nervous System Malformations
Vascular Diseases
Vascular Malformations

ClinicalTrials.gov processed this record on November 20, 2014