An observational study in Chronic Liver Disease, sponsored by University of Regensburg. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-29.
Sponsored by University of Regensburg · Observational
The immune system is thought to play a key role in the development of liver inflammation and subsequent liver fibrosis or cirrhosis.
In the case of viral hepatitis and autoimmune hepatitis, for example, numerous studies have focused on the acquired antigen-specific immunity. However, the liver is the site of increased occurrence of the components of the innate immune response (NK and NKT cells) and, in contrast to T cells, these T cells, these do not require antigen presentation.
Therefore, the present study was designed to determine which cellular components of the (NK, NKT, dendritic cells, macrophages) or the acquired immune response (CD4, CD8) or which network of immune cells is involved in the immunopathogenesis of progressive liver inflammation or the development of liver fibrosis.
The aim is to identify lymphocyte populations that exhibit either prognostically favorable or unfavorable characteristics. This should allow conclusions to be drawn for a more targeted and individualized therapy of the respective chronic liver diseases.
In patients with acute liver inflammation (e.g., autoimmune hepatitis, viral hepatitis) or chronic inflammation (e.g., ethyltoxic, viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC) or liver fibrosis, the cellular immune response will be prospectively investigated and compared with liver healthy control patients.
For this purpose, patients with known or unknown liver disease will be tested during inpatient stays or during a visit to the outpatient clinic after written consent has been obtained.
Blood is then processed for further immunological cell analyses and finally frozen in liquid nitrogen. If a liver biopsy is taken from the patient as part of the clinical diagnostics during an inpatient stay or if a liver biopsy or liver resection is performed during a procedure in the OR, tissue that is not required for diagnostic purposes should be frozen for further immunological cell analysis.
If patients undergoing elective surgery in the abdominal cavity are suspected of having a liver disease (e.g., altered liver parameters in the blood) and a wedge biopsy of the liver will be performed intraoperatively for diagnostics, tissue that is not required for diagnostic purposes should be prepared for further immunological cell analysis.
In addition, a part of the liver tissue obtained should be preserved for later genetic studies, e.g. in RNA-later.
In case of acute liver disease, further blood samples should be taken 48 and 96 h later and on weeks 1, 2, 4, 6, and 12, and after 6 and 12 months, respectively (or at the respective visits to the outpatient clinic).
For patients with chronic liver disease, blood should be re-collected during their regular visits at the outpatient clinic
In addition to patient history and medical information, the patients should also be regularly examined during the entire duration of the study and medical information, that are regularly collected during routine laboratory work ups (e.g. viral titers by quantitative PCR, liver enzymes and liver function) will be included.
To compare the immune responses, lymphocytes from patients without liver disease will be examined. will be investigated. Furthermore, healthy blood donors will be used as an additional control group.
University of Regensburg is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with chronic or acute liver disease undergoing surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with chronic liver disease up to progressive cirrhosis (e.g. ethyltoxic, Viral hepatitis, fatty liver, hepatitis, colorectal liver , HCC).
Patients with elevated liver values undergoing elective abdominal surgery.
As comparison groups patients with acute hepatitis (e.g. viral or autoimmune genesis) and patients without liver disease.
Exclusion Criteria:
Age under 18
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with either acute or chronic liver disease
Liver fibrosis
Stage of liver fibrosis in histology (Ishak-score (1 - 6))
Time frame: Day 0
Liver Steatosis
Stage of liver steatosis in histology (NASH activity score (1 - 8))
Time frame: Day 0
Survival
Overall Survival
Time frame: After 3 years
Plan to share: Undecided — Depending on data safety plan
No publications or documents are linked to this record.
Started Feb 2014 (actual). Primary completion is estimated for Jan 2023, 107 months after the start.
How these figures are worked out, and which studies are left out of them.
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