Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations
NCT ID: NCT06214767
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1200 participants
OBSERVATIONAL
2020-09-01
2026-06-30
Brief Summary
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Main Questions to Answer:
How 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.
Participants will provide clinical data, including past medical history and results of any laboratory tests.
Participants will be part of a three-year follow-up observation to monitor the progression or stability of CCMs.
Contribution of biological samples for advanced testing might also be requested.
This 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Patients who have not received invasive treatment (surgery, radiotherapy, or multimodal therapy) in the past.
3. 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.
4. 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.
5. Willingness to participate in long-term follow-up.
Exclusion Criteria
2. Patients with other intracranial diseases, such as aneurysms, tumors, or other vascular malformations, excluding developmental venous anomalies (DVA).
3. Patients with severe underlying diseases affecting their functional status and short-term life expectancy.
4. Patients with severe psychiatric or psychological disorders.
5. Incomplete clinical or imaging data.
ALL
No
Sponsors
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RenJi Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Beijing Friendship Hospital
OTHER
Guangzhou Red Cross Hospital
OTHER
Affiliated Hospital of Guangdong Medical University
OTHER
Shanxi Provincipal People's Hospital
UNKNOWN
Qilu Hospital of Shandong University
OTHER
Second Xiangya Hospital of Central South University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Beijing Tiantan Hospital
OTHER
Responsible Party
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Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Locations
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Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HX-B-2023058
Identifier Type: -
Identifier Source: org_study_id
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