Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-03-29 @ 11:37 AM
Study NCT ID:
NCT02946866
Status:
UNKNOWN
Last Update Posted:
2022-05-12
First Post:
2016-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020786', 'term': 'Hemangioma, Cavernous, Central Nervous System'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D006392', 'term': 'Hemangioma, Cavernous'}, {'id': 'D006391', 'term': 'Hemangioma'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000096826', 'term': 'Cavernous Sinus Syndromes'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020785', 'term': 'Central Nervous System Vascular Malformations'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic hemorrhage', 'timeFrame': '5 year', 'description': 'hemorrhage due to rupture of cavernous malformation'}], 'secondaryOutcomes': [{'measure': 'Symptomatic hemorrhage', 'timeFrame': '1 year', 'description': 'hemorrhage due to rupture of cavernous malformation'}, {'measure': 'All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom', 'timeFrame': '1 year', 'description': 'hemorrhage without symptom'}, {'measure': 'All hemorrhagic event including radiologic rupture', 'timeFrame': '5 year', 'description': 'all hemorrhagic events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cerebral Cavernous Malformation', 'Intracerebral Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '24681702', 'type': 'BACKGROUND', 'citation': 'Jeon JS, Kim JE, Chung YS, Oh S, Ahn JH, Cho WS, Son YJ, Bang JS, Kang HS, Sohn CH, Oh CW. A risk factor analysis of prospective symptomatic haemorrhage in adult patients with cerebral cavernous malformation. J Neurol Neurosurg Psychiatry. 2014 Dec;85(12):1366-70. doi: 10.1136/jnnp-2013-306844. Epub 2014 Mar 28.'}, {'pmid': '26654287', 'type': 'BACKGROUND', 'citation': 'Horne MA, Flemming KD, Su IC, Stapf C, Jeon JP, Li D, Maxwell SS, White P, Christianson TJ, Agid R, Cho WS, Oh CW, Wu Z, Zhang JT, Kim JE, Ter Brugge K, Willinsky R, Brown RD Jr, Murray GD, Al-Shahi Salman R; Cerebral Cavernous Malformations Individual Patient Data Meta-analysis Collaborators. Clinical course of untreated cerebral cavernous malformations: a meta-analysis of individual patient data. Lancet Neurol. 2016 Feb;15(2):166-173. doi: 10.1016/S1474-4422(15)00303-8. Epub 2015 Dec 2.'}, {'pmid': '18974380', 'type': 'BACKGROUND', 'citation': 'Al-Shahi Salman R, Berg MJ, Morrison L, Awad IA; Angioma Alliance Scientific Advisory Board. Hemorrhage from cavernous malformations of the brain: definition and reporting standards. Angioma Alliance Scientific Advisory Board. Stroke. 2008 Dec;39(12):3222-30. doi: 10.1161/STROKEAHA.108.515544. Epub 2008 Oct 30.'}, {'pmid': '9254081', 'type': 'BACKGROUND', 'citation': 'Porter PJ, Willinsky RA, Harper W, Wallace MC. Cerebral cavernous malformations: natural history and prognosis after clinical deterioration with or without hemorrhage. J Neurosurg. 1997 Aug;87(2):190-7. doi: 10.3171/jns.1997.87.2.0190.'}, {'pmid': '22302553', 'type': 'BACKGROUND', 'citation': 'Flemming KD, Link MJ, Christianson TJ, Brown RD Jr. Prospective hemorrhage risk of intracerebral cavernous malformations. Neurology. 2012 Feb 28;78(9):632-6. doi: 10.1212/WNL.0b013e318248de9b. Epub 2012 Feb 1.'}, {'pmid': '23150651', 'type': 'BACKGROUND', 'citation': 'Schneble HM, Soumare A, Herve D, Bresson D, Guichard JP, Riant F, Tournier-Lasserve E, Tzourio C, Chabriat H, Stapf C. Antithrombotic therapy and bleeding risk in a prospective cohort study of patients with cerebral cavernous malformations. Stroke. 2012 Dec;43(12):3196-9. doi: 10.1161/STROKEAHA.112.668533. Epub 2012 Nov 13.'}, {'pmid': '22297119', 'type': 'BACKGROUND', 'citation': 'Al-Shahi Salman R, Hall JM, Horne MA, Moultrie F, Josephson CB, Bhattacharya JJ, Counsell CE, Murray GD, Papanastassiou V, Ritchie V, Roberts RC, Sellar RJ, Warlow CP; Scottish Audit of Intracranial Vascular Malformations (SAIVMs) collaborators. Untreated clinical course of cerebral cavernous malformations: a prospective, population-based cohort study. Lancet Neurol. 2012 Mar;11(3):217-24. doi: 10.1016/S1474-4422(12)70004-2. Epub 2012 Jan 31.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\n* Index lesion decision criteria I. Symptomatic II. Asymptomatic (priorities are as follows)\n\n 1. Previous bleed\n 2. Brain stem location\n 3. Deep nuclei (thalamus, caudate, basal ggl, hypothalamus)\n 4. Periventricular\n 5. Largest\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators defined the cohort population as adults( more than 18 years old) with newly diagnosed cerebral cavernous malformation who agree to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed cerebral cavernous malformation who agreed to participate.\n* 18 years old or more\n\nExclusion Criteria:\n\n* Patients who underwent treatment(surgery or radiosurgery) for cavernous malformation\n* Patients who are accompanied by other serious medical problems'}, 'identificationModule': {'nctId': 'NCT02946866', 'acronym': 'CHOCOOATE', 'briefTitle': 'CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation', 'orgStudyIdInfo': {'id': 'SNUH-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cerebral cavernous malformation', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chuncheon', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'KangWon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '52727', 'city': 'Jinju', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Chuncheon', 'state': 'Kanwon', 'country': 'South Korea', 'facility': 'HUMC-Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Ilsan', 'state': 'Kyungkido', 'country': 'South Korea', 'facility': 'DongGuk University', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Jeju City', 'country': 'South Korea', 'facility': 'Jeju National University Hospital', 'geoPoint': {'lat': 33.50972, 'lon': 126.52194}}, {'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital Seoul', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JeongEun Kim, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'KangWon National University Hospital', 'class': 'OTHER'}, {'name': 'Jeju National University Hospital', 'class': 'OTHER'}, {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, {'name': 'Gyeongsang National University Hospital', 'class': 'OTHER'}, {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Suzhou Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Eun Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}