FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis (NCT02476695) | Clinical Trial Compass
CompletedNot Applicable
FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis
China412 participantsStarted 2014-05
Plain-language summary
This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference.
Actual 517 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with age 18-65 years, both gender
* Subjects with history of HBV or HBsAg positive \> 6 months up to enrollment
* Subjects with qualified liver biopsy specimens within three months (before or after) of Fibrotouch examination for pathological staging
* Subjects without chemical therapy history of powerful medicine to lower enzyme in the two weeks before blood biochemistry tests (e.g. dimethyl diphenyl bicarboxylate and bicyclol)
* Subjects must agree and sign the informed consent form
Exclusion Criteria:
* Subjects who are unable or unwilling to sign informed consent form
* Subjects who have merger of hepatitis C, alcohol and non-alcoholic fatty liver diseases, autoimmune liver diseases, inherited metabolic liver diseases, biliary systemic diseases or liver and gall parasitic diseases
* Subjects who have other serious chronic disorders or history of malignancy
* Subjects with ALT ≥5 ULN in the past 1 month
* Subjects with WBC\<3.5×10\^9/L, PLT\<60×10\^9/L, PTA\<60%
* Subjects with DBIL≥1.5 ULN
* Subjects with decompensated cirrhosis (especially the people with ascites)
* Pregnant or lactating women, or women who has a pregnant plan and don't want to birth control in the study period
* Subjects who have wound on the right upper abdomen recently
* Subjects who have various space-occupying tumor or cyst in right liver
* Subjects who have none or limited legal capacity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Clinical Value Evaluation of FibroTouch for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Hepatitis B by Using Liver Pathology as the Gold Standard for Judging CHB Liver Fibrosis Stage
Timeframe: Participants will be offered a FibroTouch examination before or after taking the test of liver biopsy, and the time interval should not exceed 3 months.