Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 11 for:    Cavernous Malformation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02946866
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Asan Medical Center
KangWon National University Hospital
Jeju National University Hospital
Chuncheon Sacred Heart Hospital
Hallym University Medical Center
SMG-SNU Boramae Medical Center
Gyeongsang National University Hospital
Soonchunhyang University Hospital
Information provided by (Responsible Party):
Jeong Eun Kim, Seoul National University Hospital

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.

Condition or disease
Cerebral Cavernous Malformation Intracerebral Hemorrhage

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 228 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation
Study Start Date : June 2016
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024


Group/Cohort
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.



Primary Outcome Measures :
  1. Symptomatic hemorrhage [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Symptomatic hemorrhage [ Time Frame: 1 year ]
  2. All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom [ Time Frame: 1 year ]
  3. All hemorrhagic event including radiologic rupture [ Time Frame: 5 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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): NCT02946866


Contacts
Layout table for location contacts
Contact: JeongEun Kim, MD. PhD. 82-2-2072-2358 eunkim@snuh.org

Locations
Layout table for location information
Korea, Republic of
KangWon National University Hospital Not yet recruiting
Chuncheon, Kangwon, Korea, Republic of
Contact: Seung Jin Lee, MD.         
Principal Investigator: Seung Jin Lee, MD.         
Sub-Investigator: Kang Min Kim, MD.         
HUMC-Chuncheon Sacred Heart Hospital Not yet recruiting
Chuncheon, Kanwon, Korea, Republic of
Contact: Jin Pyung Jeon, MD., Ph D.         
Principal Investigator: Jin Pyung Jeon, MD., Ph D.         
DongGuk University Not yet recruiting
Ilsan, Kyungkido, Korea, Republic of
Contact: Hyunho Choi, MD.         
Principal Investigator: Hyunho Choi, MD.         
Sub-Investigator: Seungyub Yang, MD. PhD.         
Gyeongsang National University Hospital Not yet recruiting
Jinju, South Gyeongsang, Korea, Republic of, 52727
Contact: In Sung Park, MD., PhD.       gnuhpis8113@gmail.com   
Principal Investigator: In Sung Park, MD., PhD.         
Jeju National University Hospital Recruiting
Jeju, Korea, Republic of
Contact: Jong Kook Rhim, MD. PhD.         
Principal Investigator: Jong Kook Rhim, MD. PhD.         
Soonchunhyang University Hospital Seoul Not yet recruiting
Seoul, Korea, Republic of, 04401
Contact: Sukh Que Park, MD., PhD.       drcolor@hanmail.net   
Principal Investigator: Sukh Que Park, MD., PhD.         
Asan Medical center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jung-cheol Park, MD. PhD.         
Sub-Investigator: Jung-cheol Park, MD. PhD.         
Principal Investigator: Jae-sung Ahn, MD. PhD.         
Sub-Investigator: Won-hyoung Park, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: JeongEun Kim, MD.PhD.         
Principal Investigator: JeongEun Kim, MD. PhD.         
Sub-Investigator: Hyun-Seung Kang, MD. PhD.         
Sub-Investigator: Won Sang Cho, MD. PhD.         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Asan Medical Center
KangWon National University Hospital
Jeju National University Hospital
Chuncheon Sacred Heart Hospital
Hallym University Medical Center
SMG-SNU Boramae Medical Center
Gyeongsang National University Hospital
Soonchunhyang University Hospital
Investigators
Layout table for investigator information
Principal Investigator: JeongEun Kim, MD. PhD. Study Principal Investigator

Publications:

Layout table for additonal information
Responsible Party: Jeong Eun Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02946866     History of Changes
Other Study ID Numbers: SNUH-002
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Abnormalities
Hemangioma, Cavernous, Central Nervous System
Hemangioma, Cavernous
Central Nervous System Vascular Malformations
Nervous System Malformations
Vascular Malformations
Cardiovascular Abnormalities
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases