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Trial record 3 of 12 for:    Cavernous Malformation

CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study (CHOCOOATE)

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ClinicalTrials.gov Identifier: NCT02946866
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Asan Medical Center
KangWon National University Hospital
Jeju National University Hospital
Chuncheon Sacred Heart Hospital
SMG-SNU Boramae Medical Center
Gyeongsang National University Hospital
Soonchunhyang University Hospital
Johannes Gutenberg University Mainz
The First Affiliated Hospital of Suzhou University
Information provided by (Responsible Party):
Jeong Eun Kim, Seoul National University Hospital

Tracking Information
First Submitted Date October 26, 2016
First Posted Date October 27, 2016
Last Update Posted Date September 20, 2019
Study Start Date June 2016
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2016)
Symptomatic hemorrhage [ Time Frame: 5 year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02946866 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 26, 2016)
  • Symptomatic hemorrhage [ Time Frame: 1 year ]
  • All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom [ Time Frame: 1 year ]
  • All hemorrhagic event including radiologic rupture [ Time Frame: 5 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study
Official Title A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation
Brief Summary The aim of this prospective study is to reveal the natural history of symptomatic hemorrhage in adult patients with cerebral cavernous malformation with the goal of informing the treatment plan.
Detailed Description

Cerebral cavernous malformation Patients with newly diagnosed, cerebral cavernous malformation who will visit one of the study centers during the period from June 2016 to December 2017. Patients would be eligible for enrollment if they were 18 years of age or older and had at least 1 cerebral cavernous malformation. If the patient had multiple cavernous malformations, index cavernous malformation would be enrolled. Index lesion will be determined according to the criteria.

  • Index lesion decision criteria I. Symptomatic II. Asymptomatic (priorities are as follows)

    1. Previous bleed
    2. Brain stem location
    3. Deep nuclei (thalamus, caudate, basal ggl, hypothalamus)
    4. Periventricular
    5. Largest

All patients who would visit a study center during the enrollment period and meet these criteria will be asked to join the study. The cohort will consists of patients who agree to participate. Target population of this study is 228 patients.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Investigators defined the cohort population as adults( more than 18 years old) with newly diagnosed cerebral cavernous malformation who agree to participate.
Condition
  • Cerebral Cavernous Malformation
  • Intracerebral Hemorrhage
Intervention Not Provided
Study Groups/Cohorts Cerebral cavernous malformation
Patients with newly diagnosed, cerebral cavernous malformation who will visit one of the study centers during the period from June 2016 to December 2017. Patients would be eligible for enrollment if they were 18 years of age or older and had at least 1 cavernous malformation. All patients who would visit a study center during the enrollment period and meet these criteria will be asked to join the study. The cohort will consists of patients who agree to participate. Target population of this study is 228 patients.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 26, 2016)
228
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with newly diagnosed cerebral cavernous malformation who agreed to participate.
  • 18 years old or more

Exclusion Criteria:

  • Patients who underwent treatment(surgery or radiosurgery) for cavernous malformation
  • Patients who are accompanied by other serious medical problems
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: JeongEun Kim, MD. PhD. 82-2-2072-2358 eunkim@snuh.org
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02946866
Other Study ID Numbers SNUH-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jeong Eun Kim, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators
  • Asan Medical Center
  • KangWon National University Hospital
  • Jeju National University Hospital
  • Chuncheon Sacred Heart Hospital
  • SMG-SNU Boramae Medical Center
  • Gyeongsang National University Hospital
  • Soonchunhyang University Hospital
  • Johannes Gutenberg University Mainz
  • The First Affiliated Hospital of Suzhou University
Investigators
Principal Investigator: JeongEun Kim, MD. PhD. Study Principal Investigator
PRS Account Seoul National University Hospital
Verification Date September 2019