Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05256459 |
Other study ID # |
Zhangdz2017 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 10, 2022 |
Est. completion date |
December 15, 2024 |
Study information
Verified date |
May 2022 |
Source |
The Second Affiliated Hospital of Chongqing Medical University |
Contact |
Linhan Li, Master |
Phone |
17623676495 |
Email |
741789028[@]qq.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This study aims to explore whether there is difference in the incidence rate and incidence
rate of HCC in patients with chronic hepatitis B who are screened for high risk of liver
cancer. Whether the timely intervention can be used to reduce the incidence of HCC for the
early screening and early warning patients can provide evidence-based medical evidence for
the selection or adjustment of anti HBV drugs in high-risk patients with liver cancer. To
provide evidence for whether patients with liver nodules at high risk of liver cancer need to
deal with liver nodules in advance.
Description:
This study is a multicenter, prospective clinical study. Including the Second Affiliated
Hospital of Chongqing Medical University, the Third Affiliated Hospital of Chongqing Medical
University, the First Affiliated Hospital of Southwest Medical University, Chongqing public
health treatment center and the Three Gorges central hospital.
Firstly, patients were screened for peripheral blood cfdna gene to screen patients with high
risk of liver cancer. High risk patients were examined for high-precision HBV-DNA
quantification, liver function, AFP, abdominal imaging (color Doppler ultrasound, CT or MR),
blood map, HIV syphilis screening, anti HDV, anti HCV, etc. according to the results of
high-precision HBV-DNA quantification (lower than the detection limit (< 10 IU / ml), ≥ 10 IU
/ ml, non negative ones are uniformly called positive), and patients are divided into 2
groups according to the wishes of patients, with 50 cases in each group. The observation
group includs those who did not deal with nodules and were closely followed up,another group
is treatment group,includs those who with hepatic nodules were treated by radiofrequency
ablation and/or surgery and so on. Follow up examinations were conducted every 3 months to
the center. The follow-up period lasted for 3 years. Clinical data were recorded, incidence
rate of liver cancer, occurrence time of liver cancer and incidence of adverse events in
liver were recorded.
Research implementation process and route
1. Recruitment object: after the approval of the ethics committee, the recruitment was
started in each experimental center, the basic information and various examination
indexes of the patients were collected, and the patients were informed that they needed
to go to the outpatient clinic of our hospital for follow-up examination every 3 months,
with a total follow-up of 3 years.
2. Establishment of information archives: in addition to recording the basic information
and examination results of patients, it also includes the time when patients should be
followed up in our hospital. Contact and inform patients in advance before each
follow-up time. At the same time, special clinical events during follow-up were
recorded.
3. Statistical analysis: after a three-year follow-up, the data collected by each center
were tested by t-test and multivariate Cox analysis to analyze the time when patients in
each group developed into primary liver cancer and the incidence of primary liver cancer
in each group.
4. Data to be collected: general medical history characteristics: medical record number,
name, gender, age, disease degree (whether there is decompensation / compensation of
liver cirrhosis, whether there is liver nodule, etc.), enrollment time, contact
information, whether to drink alcohol and medication. Examination and inspection
indicators: liver function, renal function, blood chart analysis, hepatitis B two half
and half, anti HCV, anti HDV, AIDS syphilis screening, high precision HBV-DNA
quantification, abdominal color Doppler ultrasound (if necessary CT or MR), liver
transient elastography, liver cirrhosis patients need additional coagulation. Patients
undergoing radiofrequency ablation or surgical treatment of liver nodules need to record
the operation time and mode.
5. Follow up: after enrollment, the relevant examination indexes were rechecked every 3
months. The follow-up period was 3 years.
6. Patients with new liver diseases and decompensated complications of liver cirrhosis also
need to be recorded.