Study on Treatment Decision-Making and Prognostic Follow-Up for Untreated Cerebral Cavernous Malformations

NCT ID: NCT06214767

Last Updated: 2025-07-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2026-06-30

Brief Summary

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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).

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.

Detailed Description

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Conditions

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Hemangioma, Cavernous, Central Nervous System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of CCM based on brain MRI (T1, T2, SWI, and T2-Fluid-Attenuated Inversion Recovery).
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

1. Patients with acute intracranial symptomatic hemorrhage requiring emergency surgery.
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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

Guangzhou Red Cross Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Guangdong Medical University

OTHER

Sponsor Role collaborator

Shanxi Provincipal People's Hospital

UNKNOWN

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Shuo

Director of Department of Cerebrovascular Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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shuo wang

Role: CONTACT

13801180330

Facility Contacts

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JUN WU, MD

Role: primary

+8613426322945

Other Identifiers

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HX-B-2023058

Identifier Type: -

Identifier Source: org_study_id

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