Biobank for patients with autoimmune disease, especially autoimmune liver disease
- Conditions
- K70-K77Diseases of liver
- Registration Number
- DRKS00031385
- Lead Sponsor
- niversitätsklinikum Aachen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Diagnosis of autoimmune (liver)disease
liver biopsy as part of clinical work up
informed consent
Exclusion Criteria
<18
unwilling/no consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i. Absolute and relative changes in standard laboratory tests for liver function or immune function.<br>ii. Proportion of patients with treatment response during ongoing therapy.<br>iii. Development of clinical scoring systems during the observation period.<br>iv. Comparison and evaluation of new diagnostic systems.<br>v. The occurrence of one of the following events:<br><br>Death<br>Liver transplantation<br>MELD score > 15<br>Treatment-refractory ascites<br>Hospitalization for one of the following reasons:<br>a. Variceal bleeding<br>b. Overt hepatic encephalopathy<br>c. Spontaneous bacterial peritonitis<br>d. Hepatocellular carcinoma<br>e. Development of advanced fibrosis or cirrhosis (confirmed by biopsy, transient elastography, or risk models)<br>f. Recurrence of autoimmune liver disease after liver transplantation as well as graft failure.
- Secondary Outcome Measures
Name Time Method no defined outcomes