- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06368349
Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma
April 16, 2024 updated by: Chang Gung Memorial Hospital
Persistent Lymphopenia as a Prognostic Indicator in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma Recipients
A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019.
Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed.
In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry.
Study Overview
Status
Completed
Conditions
Detailed Description
A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019.
Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed including overall survival, recurrence-free survival, association between clinical parameter with mortality, patient characteristics by pre-lymphopenia and post-lymphopenia levels and lymphocyte status of HCC patients with usage of different immunosuppressants.
In prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry to identify the major immune cell subsets and the characteristics of patients in the prospective cohort between pre-LT lymphopenia and non-lymphopenia groups.
Study Type
Observational
Enrollment (Actual)
190
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 833
- Department of Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
A total of 190 Liver transplantation (LT) recipients were enrolled including 145 cases for retrospective and 45 cases for perspective
Description
Inclusion Criteria:
- liver transplant patient
Exclusion Criteria:
- End-stage liver disease scoring system score (MELD score) > 25
- Have received care in the intensive care unit (ICU) before transplantation
- Poor cardiovascular function.
- Patients suffering active infection.
- Other complications affecting living donor liver transplantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient
Time Frame: From March 2022 to June 2023
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A significant decrease in cell counts and percentage of overall T cells in the peritransplant lymphopenia group.
In particular, the counts of T cell subsets, T helper cells, and cluster of differentiation 8 (CD8+) cytotoxic/activated T cells significantly decreased in the peritransplant lymphopenia group with all of their naïve, effector, and memory forms.
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From March 2022 to June 2023
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Persistent lymphopenia predict poor overall survival
Time Frame: From 2006 to 2019
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The clinical records of 145 patients with HCC from seven days pre-LT to one-year post-LT illustrated that the longitudinal values of lymphocytes were persistently low in patients with peritransplant high neutrophil lymphocyte ratio, indicating a significant decrease in survival rate when compared to other patients.
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From 2006 to 2019
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Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use
Time Frame: From 2006 to 2019
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In the subset of 116 of 145 HCC recipients (80%) who did not experience or recover from lymphopenia, no significant associations were observed with immunosuppressant use.
Surprisingly, HCC recipients with long-term peritransplant lymphopenia exhibited a significant association with increased sirolimus use (p = 0.024) and decreased tacrolimus use (p = 0.001), whereas those with post-LT lymphopenia showed no association with the use of different immunosuppressants.
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From 2006 to 2019
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
June 21, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
April 11, 2024
First Submitted That Met QC Criteria
April 11, 2024
First Posted (Actual)
April 16, 2024
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Hematologic Diseases
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Leukopenia
- Leukocyte Disorders
- Cytopenia
- Carcinoma, Hepatocellular
- Lymphopenia
Other Study ID Numbers
- 202101771B0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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