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Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina. (TOUCH)

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ClinicalTrials.gov Identifier: NCT03467295
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Fuxin Lin, First Affiliated Hospital of Fujian Medical University

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.

Condition or disease Intervention/treatment
Cerebral Cavernous Malformations Procedure: Surgery Procedure: Observation

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHINA (TOUCH): A Nationwide Multicenter Prospective Cohort Study.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023


Group/Cohort Intervention/treatment
Surgically treated group
Surgical removal of intracerebral CMs by craniotomy with or without following stereotactic radiosurgery.
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.

Conservatively treated group
Observation with the best medicine administration and supportive treatment are performed.
Procedure: 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.




Primary Outcome Measures :
  1. Poor outcome [ Time Frame: 3 years ]
    The primary outcome of this study is patients with poor outcome (mRS>2 lasting at least 1year) at the last follow up.


Secondary Outcome Measures :
  1. symptomatic hemorrhage [ Time Frame: 3 years ]
    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.

  2. drug refractory epilepsy [ Time Frame: 3 years ]
    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. All-cause mortality [ Time Frame: 3 years ]
    Death caused by all the causes



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with untreated cerebral cavernous malformation are enrolled from 20 Grade Ⅲ 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467295


Contacts
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Contact: Fuxin Lin, MD 13552358381 lfxstudy@126.com
Contact: Dezhi Kang, MD,PHD 13859099988 kdz99988@vip.sina.com

Locations
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China, Fujian
The first affiliated hospital of fujian medical university Recruiting
Fuzhou, Fujian, China, 350005
Contact: Fuxin Lin, MD    13552358381    lfxstudy@126.com   
Principal Investigator: Dezhi Kang, PHD,MD         
Sub-Investigator: Fuxin Lin, MD         
Sponsors and Collaborators
First Affiliated Hospital of Fujian Medical University
Investigators
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Study Chair: Dezhi Kang, MD,PHD First Affiliated Hospital of Fujian Medical University

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Responsible Party: Fuxin Lin, Principal Investigator, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT03467295     History of Changes
Other Study ID Numbers: FAHFMU-2018-003
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share individual participant data after the primary results have been published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fuxin Lin, First Affiliated Hospital of Fujian Medical University:
Cavernous Malformations, treatment.
Additional relevant MeSH terms:
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Hemangioma, Cavernous, Central Nervous System
Congenital Abnormalities
Hemangioma, Cavernous
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Central Nervous System Vascular Malformations
Nervous System Malformations
Nervous System Diseases
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Hemostatic Disorders
Vascular Diseases
Hemorrhagic Disorders
Hematologic Diseases