Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-02 @ 8:49 AM
Study NCT ID:
NCT04593966
Status:
UNKNOWN
Last Update Posted:
2020-10-20
First Post:
2020-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002538', 'term': 'Intracranial Arteriovenous Malformations'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'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': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-10-19', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Ranking Scale score at 2 weeks after the operation', 'timeFrame': '2 weeks', 'description': 'The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.\n\nNo significant disability. Able to carry out all usual activities, despite some symptoms.\n\nSlight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n\nModerate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n\nSevere disability. Requires constant nursing care and attention, bedridden, incontinent.\n\nDead'}, {'measure': 'modified Ranking Scale score when discharge', 'timeFrame': 'Discharge (assessed up to 10 days)', 'description': 'The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.\n\nNo significant disability. Able to carry out all usual activities, despite some symptoms.\n\nSlight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n\nModerate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n\nSevere disability. Requires constant nursing care and attention, bedridden, incontinent.\n\nDead'}, {'measure': 'modified Ranking Scale score at 1 years after the operation', 'timeFrame': '1 years', 'description': 'The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.\n\nNo significant disability. Able to carry out all usual activities, despite some symptoms.\n\nSlight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n\nModerate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n\nSevere disability. Requires constant nursing care and attention, bedridden, incontinent.\n\nDead'}, {'measure': 'modified Ranking Scale score at 3 years after the operation', 'timeFrame': '3 years', 'description': 'The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.\n\nNo significant disability. Able to carry out all usual activities, despite some symptoms.\n\nSlight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n\nModerate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n\nSevere disability. Requires constant nursing care and attention, bedridden, incontinent.\n\nDead'}], 'secondaryOutcomes': [{'measure': 'Obliteration rate', 'timeFrame': 'At least 1 year, up to 3 years', 'description': 'Confirmed by postoperative DSA or MRI/magnetic resonance angiography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Arteriovenous Malformation']}, 'descriptionModule': {'briefSummary': "Cerebral Arteriovenous malformations (AVMs) are abnormal tangles which are usually believed congenital. AVM can cause different symptoms depending on where it is located, but the most common symptoms are intracranial hemorrhage and seizure. Outcomes of AVM patients can be very different due to factors like the location of lesion, age, sex etc. Generally, more early the intervention was taken, the risk of adverse events would be lower. But the selection of surgical timing for pediatric AVM patients is hard to judge, due to children's cerebral vessels angioarchitecture can be still developing with their age. Some previous studies indicated that there is no difference in intervention outcomes between pediatric and adult AVM patients, so pediatric patients should undergo more aggressive intervention. DOPA study aims to compare the clinical intervention outcomes of both pediatric and adult patients with eloquent region cerebral arteriovenous malformations, helping to determine the treatment strategy.", 'detailedDescription': "Follow-up: In the investigators' neurosurgical center, follow-up was conducted for all participants at the first 3-6 months and annually after discharge by clinical visit and telephone interview.\n\nStudy overview: DOPA will aim on outcomes of both pediatric and adult AVMs patients who underwent intervention in investigators' institution. Intervention strategies contains microsurgical resection, embolization, embolization + radiosurgery, and single-stage hybrid surgery (embolization + resection). Outcomes will be measured by a neurologist using Modified Rankin Scale (mRs). Participants' mRs\\<2 will be considered as a good outcome and investigators will keep follow-up with every patient for at least 3 years.\n\nSample size: About 300 patients will be enrolled in this study, and adults and children will account for half. All kinds of intervention will be included. The distribution of different strategies is excepted as: 30% resection, 20% embolization, 30% embolization + radiosurgery and 20% hybrid surgery.\n\nStudy endpoints: The patients' mRs, occlusion rate and complication will be evaluated at 2 weeks, discharge from hospital, 1 year and 3 years after the first-time intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with brain arteriovenous malformation which located in eloquent area.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).\n* Patients had underwent interventions in our institution.\n* AVMs were located in eloquent area.\n\nExclusion Criteria:\n\n* Patients with multiple AVMs.\n* Patients with hereditary hemorrhagic telangiectasia (HHT).\n* Patients with missing clinical and imaging data.'}, 'identificationModule': {'nctId': 'NCT04593966', 'acronym': 'DOPA', 'briefTitle': 'Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Differences of Long-term Neurofunctional Outcomes in Pediatric and Adult Eloquent Region Cerebral Arteriovenous Malformation', 'orgStudyIdInfo': {'id': 'KY 2019/0917'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric AVM', 'description': "1. AVM patients' age under 18-years-old who underwent intervention in investigators' institution.\n2. Patients' lesions were located in eloquent and confirmed by image."}, {'label': 'Adult AVM', 'description': "1. AVM patients' age over 18-years-old who underwent intervention in investigators' institution.\n2. Patients' lesions were located in eloquent and confirmed by image."}]}, 'contactsLocationsModule': {'locations': [{'zip': '101100', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruinan Li, MD', 'role': 'CONTACT', 'email': '70akagi@gmail.com', 'phone': '+8618511287842'}], 'facility': 'Capital medical university affiliated Beijing Tiantan hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ruinan Li, MD', 'role': 'CONTACT', 'email': '70akagi@gmail.com', 'phone': '+8618511287842'}, {'name': 'Yuanli Zhao, MD', 'role': 'CONTACT', 'email': 'zhaoyuanli@126.com', 'phone': '+8601069006284'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'yuanli Zhao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University International Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman of Neurosurgical center', 'investigatorFullName': 'yuanli Zhao', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}