Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina.

Cerebral Cavernous Malformations Clinical Trial

— TOUCH  

Official title:

Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHINA (TOUCH): A Nationwide Multicenter Prospective Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03467295
• Other study ID #: FAHFMU-2018-003
• Status: Recruiting
• First received: March 9, 2018
• Last updated: March 15, 2018
• Start date: January 1, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2018
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Fuxin Lin, MD
• Phone: 13552358381
• Email: lfxstudy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Despite the availability of microsurgical excision and stereotactic radiosurgery for cavernoma treatment and known genetic causes of most familial forms of cavernoma, uncertainties remain about cause, diagnosis, prognosis, treatment, and care. According to the recently published CM treatment guideline, surgical and conservative treatments are both first-line therapeutic options in previously untreated CMs (U-CMs). However, given current data, neurosurgeons are still unable to counsel patients on which would be the best option. To address the absence of high level evidence to support cerebral CM treatment decisions, there is a need for a large sample size study of cerebral CM treatment with a prospective concurrent group. China has the largest population in the world and may have the most extensive and valuable clinical resources of U-CMs. But, till now, the current treatment and outcome situation of the disease in China is not well known. Thus, the investigators are conducting a nationwide multicenter prospective registry study in China to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.At least 2000 patients with untreated cerebral cavernous malformation will be enrolled from 20 Grade Ⅲ A level hospitals distributed all over China. Clinical data and laboratory data are prospectively collected by electric case report form (CRF) and uploaded online by each neurosurgery center to form the prospective clinical database in First Affiliated Hospital of Fujian Medical University. This is a cohort follow-up study across a 5-year period with a 2 years interval of enrollment and 3 years follow up for each patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Cavernous Malformations
• Congenital Abnormalities

Intervention

Procedure:
• Surgery
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
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.

Locations

Country	Name	City	State
China	The first affiliated hospital of fujian medical university	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	symptomatic hemorrhage	Requiring acute or subacute onset symptoms (any of headache, epileptic seizure, impaired consciousness, or new/worsened brain function deficit referable to the anatomic location of the CM) accompanied by radiological, pathological, surgical, or rarely only cerebrospinal fluid evidence of recent extra- or intralesional hemorrhage.	3 years
Secondary	drug refractory epilepsy	Failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.	3 years
Secondary	All-cause mortality	Death caused by all the causes	3 years