Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina.

Brief Title

Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina.

Official Title

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

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.
    

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.
    


Study Type

Observational


Primary Outcome

Poor outcome

Secondary Outcome

 symptomatic hemorrhage

Condition

Cerebral Cavernous Malformations

Intervention

Surgery

Study Arms / Comparison Groups

 Surgically treated group
Description:  Surgical removal of intracerebral CMs by craniotomy with or without following stereotactic radiosurgery.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

2000

Start Date

January 1, 2018

Completion Date

March 31, 2023

Primary Completion Date

March 31, 2023

Eligibility 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.
      

Gender

All

Ages

N/A - N/A


Contacts

Dezhi Kang, MD,PHD, 13552358381, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03467295

Organization ID

FAHFMU-2018-003


Responsible Party

Principal Investigator

Study Sponsor

First Affiliated Hospital of Fujian Medical University


Study Sponsor

Dezhi Kang, MD,PHD, Study Chair, First Affiliated Hospital of Fujian Medical University


Verification Date

March 2018