Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT06214767
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2024-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020786', 'term': 'Hemangioma, Cavernous, Central Nervous System'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Outcome:mRS', 'timeFrame': '3 years', 'description': 'Last follow-up with a modified Rankin Scale (mRS) score greater than 2 persisting for at least one year'}], 'secondaryOutcomes': [{'measure': 'Radiological Outcome:Bleeding', 'timeFrame': '3 years', 'description': 'Bleeding is defined as the presence of new hemorrhage identified on radiological imaging in patients.'}, {'measure': 'Radiological Outcome:Increase in lesion volume', 'timeFrame': '3 years', 'description': 'An increase in lesion volume is defined as a 20% or more increase in the size of the lesion, as shown by follow-up imaging compared to previous measurements.'}, {'measure': 'Syndrome Outcome:Drug-resistant epilepsy', 'timeFrame': '3 years', 'description': 'Epilepsy is considered drug-resistant when a person has failed to achieve sustained seizure freedom despite adequate trials of two appropriate and well-tolerated antiepileptic drug regimens, either as monotherapies or in combination.'}, {'measure': 'Syndrome Outcome:Focal neurological deficits', 'timeFrame': '3 years', 'description': 'Focal neurological deficits can manifest as weakness, numbness, loss of coordination, or changes in sensation specific to the affected area, and are typically indicative of underlying neurological conditions or injuries.'}, {'measure': 'All-cause mortality', 'timeFrame': '3 years', 'description': 'All-cause mortality refers to the proportion of deaths due to any cause within the follow-up period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemangioma, Cavernous, Central Nervous System']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate and predict the risk associated with cerebral cavernous malformations (CCMs) using advanced artificial intelligence and radiomics analysis technology. The study focuses on individuals who have been diagnosed with cerebral cavernous malformations (CCMs).\n\nMain Questions to Answer:\n\nHow can AI-based radiomics features predict the risk of complications (such as bleeding or epilepsy) in individuals with CCMs? What are the most reliable imaging and clinical markers for assessing the prognosis of CCMs? Participants will be required to undergo regular medical imaging to gather traditional and radiomics imaging features.\n\nParticipants will provide clinical data, including past medical history and results of any laboratory tests.\n\nParticipants will be part of a three-year follow-up observation to monitor the progression or stability of CCMs.\n\nContribution of biological samples for advanced testing might also be requested.\n\nThis study aims to create an AI-based decision-making tool that will guide clinicians in the management of CCM, with the potential to significantly improve patient outcomes through personalized medical approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Untreated cerebral cavernous malformation patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of CCM based on brain MRI (T1, T2, SWI, and T2-Fluid-Attenuated Inversion Recovery).\n2. Patients who have not received invasive treatment (surgery, radiotherapy, or multimodal therapy) in the past.\n3. Patients undergoing surgery, or their legal guardians, agree to collect lesion tissue samples for related studies and sign a consent form for the collection of biological samples.\n4. Patients under conservative observation, or their legal guardians, agree to collect imaging data for related research and sign a consent form for the use of imaging data.\n5. Willingness to participate in long-term follow-up.\n\nExclusion Criteria:\n\n1. Patients with acute intracranial symptomatic hemorrhage requiring emergency surgery.\n2. Patients with other intracranial diseases, such as aneurysms, tumors, or other vascular malformations, excluding developmental venous anomalies (DVA).\n3. Patients with severe underlying diseases affecting their functional status and short-term life expectancy.\n4. Patients with severe psychiatric or psychological disorders.\n5. Incomplete clinical or imaging data.'}, 'identificationModule': {'nctId': 'NCT06214767', 'briefTitle': 'Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations', 'orgStudyIdInfo': {'id': 'HX-B-2023058'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'JUN WU, MD', 'role': 'CONTACT', 'email': 'wujunslf@126.com', 'phone': '+8613426322945'}, {'name': 'Shuo Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Capital Medical University Affiliated Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'shuo wang', 'role': 'CONTACT', 'email': 'captain9858@126.com', 'phone': '13801180330'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'Guangzhou Red Cross Hospital', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Guangdong Medical University', 'class': 'OTHER'}, {'name': "Shanxi Provincipal People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Cerebrovascular Neurosurgery', 'investigatorFullName': 'Wang Shuo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}