Study on Treatment Decision-Making and Prognostic Follow-... | NCT06214767

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

NCT06214767

Sponsor

Beijing Tiantan Hospital

Status

Recruiting

Last Update Posted

Jul 30, 2025Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Hemangioma, Cavernous, Central Nervous System

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Jan 10, 2024

First Submission Date that Met QC Criteria

Jan 10, 2024

First Posted Date

Jan 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2025

Last Update Posted Date

Jul 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wang Shuo, Director of Department of Cerebrovascular Neurosurgery, Beijing Tiantan HospitalPrincipal Investigator

Lead Sponsor

Beijing Tiantan HospitalOTHER

Collaborators

Name	Class
RenJi Hospital	OTHER
Beijing Chao Yang Hospital	OTHER
Beijing Friendship Hospital	OTHER
Guangzhou Red Cross Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional Outcome:mRS	Last follow-up with a modified Rankin Scale (mRS) score greater than 2 persisting for at least one year	3 years

Secondary Outcomes

Measure	Description	Time Frame
Radiological Outcome:Bleeding	Bleeding is defined as the presence of new hemorrhage identified on radiological imaging in patients.	3 years
Radiological Outcome:Increase in lesion volume	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of CCM based on brain MRI (T1, T2, SWI, and T2-Fluid-Attenuated Inversion Recovery).
Patients who have not received invasive treatment (surgery, radiotherapy, or multimodal therapy) in the past.
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.
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.
Willingness to participate in long-term follow-up.

Exclusion Criteria:

Patients with acute intracranial symptomatic hemorrhage requiring emergency surgery.
Patients with other intracranial diseases, such as aneurysms, tumors, or other vascular malformations, excluding developmental venous anomalies (DVA).
Patients with severe underlying diseases affecting their functional status and short-term life expectancy.
Patients with severe psychiatric or psychological disorders.
Incomplete clinical or imaging data.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Untreated cerebral cavernous malformation patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shuo wang	Contact	13801180330		captain9858@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Capital Medical University Affiliated Beijing Tiantan Hospital	Recruiting	Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020786	Hemangioma, Cavernous, Central Nervous System

Ancestor Terms

ID	Term
D006392	Hemangioma, Cavernous
D006391	Hemangioma
D009383	Neoplasms, Vascular Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided