Persistent Lymphopenia as a Prognostic Indicator in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma Recipients
Conditions: Lymphopenia
Sponsor: Chang Gung Memorial Hospital

Official title: Persistent Lymphopenia in Liver Transplantation and Its Molecular 
Insights for Hepatocellular Carcinoma 
NCT number: 
Document date: 2021/10/20 
Study Protocol and Statistical Analysis Plan: 
The subjects of this study were HCC patients with low lymphocytes (experimental 
group) and normal lymphocytes (control group). The sample type was blood and was 
divided into two parts: retrospective and prospective. 
The source of retrospective blood (including serum, plasma or white blood cells) is to 
apply for specimens from tissue banks and biobank of Kaohsiung Chang Gung 
Memorial Hospital (KCGMH). At the same time, the patient's medical record, such as 
gender, age, lymph node, etc. will also be requested. The number of cells, total 
number of white blood cells, survival, recurrence, biochemical test data and other 
information are collected. 
Prospective blood is newly collected. The source is that during the patient's 
treatment, about 20ml blood is drawn during routine examinations. This will not 
increase the burden on the patient. We will ask the patient one week before 
collecting the specimen if he is willing to provide the specimen for research purposes, 
and we guarantee that his personal information and privacy will not be disclosed. 
Unused specimens will be destroyed after the research is completed. 
We will perform retrospective analysis at first. 145 HCC patients will be divided into 2 
groups with or without lymphopenia, followed by comparing the effects of clinical 
data between them.  Blood samples will be collected to analyze the impact and 
expression of protein, gene and microRNA (miRNA). Next Generation Sequencing 
(NGS) will be applied to find unknown important factors. In prospective study, 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 
validate previous results. 
One-way analysis of variance will be used with Bonferroni’s post hoc analysis for 
comparison between multiple groups. Student’s t test will be used for comparison of 
continuous data between two groups while chi-square for discrete data. Significance 
is defined as P < 0.05.