Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina.
TOUCH
1 other identifier
observational
2,000
1 country
1
Brief Summary
This nationwide multicenter prospective cohort study will collect the treatment information and outcomes of the patients with previously untreated cavernous malformations (U-CMs) in China (at least 2000 patients from 20 centers). The investigators aim to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 9, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedMarch 19, 2018
March 1, 2018
5.2 years
March 9, 2018
March 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Poor outcome
The primary outcome of this study is patients with poor outcome (mRS\>2 lasting at least 1year) at the last follow up.
3 years
Secondary Outcomes (3)
symptomatic hemorrhage
3 years
drug refractory epilepsy
3 years
All-cause mortality
3 years
Study Arms (2)
Surgically treated group
Surgical removal of intracerebral CMs by craniotomy with or without following stereotactic radiosurgery.
Conservatively treated group
Observation with the best medicine administration and supportive treatment are performed.
Interventions
For patient in surgically treated group, surgical removal of intracerebral CMs by craniotomy is performed according to the principles as follows: less transgression of normal brain tissue; identification and protection of eloquent brain tissue; sparing associated developmental venous anomaly; hemosiderin rim resection for non-eloquent and superficial CMs and sparing yellowish tissue for eloquent and deep ones; Extended resections (mesial resection, standard temporal lobe resection) are recommend for epileptogenic CMs based on intra-operative EEG.
Observation is performed in conservatively treated patients with best medicine and supportive treatment, such as antiepileptic drugs, analgesic drugs and neurotrophic drugs. For patients with underlying diseases such as hypertension, hyperlipidemia or diabetes mellitus, after consulting with the relevant experts, the patients can be treated accordingly.
Eligibility Criteria
Consecutive patients with untreated cerebral cavernous malformation are enrolled from 20 Grade â…¢ A level hospitals distributed all over China. At the time of the participants entered the study, lesions should not have been treated by surgery or radiosurgery previously. This is a cohort follow-up study across a 5-year period. All patients in this study should meet the inclusion and exclusion criteria. Informed written consent should be obtained from eligible adult patients or from the guardians of eligible pediatric patients. All patients in the prospective part of this study can withdraw at any time.
You may qualify if:
- Definite diagnosis of cerebral CM on the basis of brain MRI or pathologic examination;
- Patients without any surgical intervention (microsurgery, radiosurgery, or multimodality treatment) before enrolment;
- Informed consent, and willing to accept long-term follow-up.
You may not qualify if:
- Patients receiving emergency surgery due to acute intracranial hematoma and resultant brain hernia;
- Patients with other never system diseases, such as aneurysms, tumors or other vascular malformations except venous development anomaly;
- Patients with severe underlying disease, which affects the patient's functional status and life expectancy;
- Patients with severe mental or psychologic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first affiliated hospital of fujian medical university
Fuzhou, Fujian, 350005, China
Related Publications (2)
Li C, Huang S, Li Q, Zhuo L, Kang Y, Liu P, Huang W, Ma K, Lin X, Zhuang W, Chen D, Wang H, Yan L, Wang D, Lin Y, Kang D, Lin F. Plasma biomarkers in patients with familial cavernous malformation and their first-degree relatives: a cross-sectional study. Sci Rep. 2025 Apr 2;15(1):11284. doi: 10.1038/s41598-025-91141-6.
PMID: 40175401DERIVEDLin F, He Q, Gao Z, Yu L, Wang D, Zheng S, Lin Y, Kang D. Treatments and outcomes of untreated cerebral cavernous malformations in China: study protocol of a nationwide multicentre prospective cohort study. BMJ Open. 2020 Oct 29;10(10):e037957. doi: 10.1136/bmjopen-2020-037957.
PMID: 33122314DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dezhi Kang, MD,PHD
First Affiliated Hospital of Fujian Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 9, 2018
First Posted
March 16, 2018
Study Start
January 1, 2018
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
March 19, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
We will share individual participant data after the primary results have been published.