Ignite Creation Date:
2025-12-18 @ 9:37 AM
Ignite Modification Date:
2025-12-18 @ 9:37 AM
Study NCT ID:
NCT04943978
Status:
None
Last Update Posted:
2021-06-29 00:00:00
First Post:
2021-06-21 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Studies on Immunopathogenesis of Liver Fibrosis
Sponsor:
None
Organization:
Study Overview
Official Title:
Prospective Studies on the Immunopathogenesis of Fibrosis in Acute and Chronic Liver Diseases
Status:
None
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: