Trial Outcomes & Findings for FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis (NCT NCT02476695)

Results Overview

Altogether 412 patients were included to analyze the diagnostic performance of FibroTouch. The area under the receiver operating characteristic curve for the LSM was 0.846 (95% confidence interval CI 0.808-0.880) for fibrosis stage ≥ F1, 0.850 for ≥ F2, 0.908 for ≥ F3 and 0.874 for F4. Optimal LSM cut-off values for diagnosing fibrosis stage ≥ F1, ≥ F2, ≥ F3, and F4 were 5.5 kPa, 7.85 kPa, 10.0 kPa, and 12.7 kPa, respectively.

Recruitment status

COMPLETED

Target enrollment

412 participants

Primary outcome 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.

Results posted on

2025-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	All Enrollment Patients Patients with chronic hepatitis B who underwent a liver biopsy and LSMwere considered for enrollment. F0, no fibrosis; F1, portal fibrosis without septa; F2, portal fibrosis and a few septa; F3, numerous septa without cirrhosis; and F4, cirrhosis. Clinical and laboratory investigations; Non-invasive serum markers of liver fibrosis; LSM by FibroTouch transient elastography; Assessment of liver pathology
Overall Study STARTED	412
Overall Study F0	11
Overall Study F1	162
Overall Study F2	118
Overall Study F3	95
Overall Study F4	26
Overall Study COMPLETED	412
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Chronic Hepatitis B n=412 Participants The METAVIR scoring system classifies liver fibrosis in five stages as follows: F0=no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = liver cirrhosis (compensatory stage) Clinical and laboratory investigations; Non-invasive serum markers of liver fibrosis; Non-invasive serum markers of liver fibrosis; Assessment of liver pathology
Age, Continuous	39.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	276 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	412 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

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.

Population: ROC analysis is based on a binary classification model, which refers to models with only two types of output results, such as: (positive/negative) (diseased/not diseased).Due to the particularity of this analysis method, there is no ROC value for F0.

Altogether 412 patients were included to analyze the diagnostic performance of FibroTouch. The area under the receiver operating characteristic curve for the LSM was 0.846 (95% confidence interval CI 0.808-0.880) for fibrosis stage ≥ F1, 0.850 for ≥ F2, 0.908 for ≥ F3 and 0.874 for F4. Optimal LSM cut-off values for diagnosing fibrosis stage ≥ F1, ≥ F2, ≥ F3, and F4 were 5.5 kPa, 7.85 kPa, 10.0 kPa, and 12.7 kPa, respectively.