Clinical trial · Observational
Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina.
Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHINA (TOUCH): A Nationwide Multicenter Prospective Cohort Study.
NCT03467295CI-TRIAL-00032129TOUCHunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebral Cavernous Malformations | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Surgically treated group
- description
- Surgical removal of intracerebral CMs by craniotomy with or without following stereotactic radiosurgery.
- interventionNames
- Procedure: Surgery
- label
- Conservatively treated group
- description
- Observation with the best medicine administration and supportive treatment are performed.
- interventionNames
- Procedure: Observation
Primary outcomes (1)
- measure
- Poor outcome
- timeFrame
- 3 years
- description
- The primary outcome of this study is patients with poor outcome (mRS\>2 lasting at least 1year) at the last follow up.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (2)
- DERIVEDLi 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 40175401
- DERIVEDLin 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 33122314