Serum Regucalcin Level and Chronic Hepatitis B

NCT05435599 | Completed

• 1 other identifier: 10542
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Conditions

Chronic Hepatitis b; Liver Fibrosis

Keywords

hepatitis b; fibrosis; regucalcin; liver

Outcome Measures

Primary Outcomes (1)

• Comparison of serum regucalcin levels with liver fibrosis levels

  We grouped chronic hepatitis b patients as mild fibrosis (stage 1-2) and moderate fibrosis (stage 3-4) according to the fibrosis stage at liver biopsy stage. We selected healthy volunteers without liver disease as the control group. We will measure the serum regucalcin level in these 3 groups and make a comparison between the groups. We want to show the relationship between serum regucalcin level and fibrosis level in chronic hepatitis b.

  Performing liver biopsies: 3 months, data collection: 1 month, writing the article: 1 month

Study Arms (2)

Chronic Hepatitis B

OTHER

Measurement of serum regucalcin level

Diagnostic Test: Serum regucalcin level

Healthy Volunteers

OTHER

Measurement of serum regucalcin level

Diagnostic Test: Serum regucalcin level

Interventions

Serum regucalcin level DIAGNOSTIC_TEST

During routine outpatient controls, serum regucalcin level will be measured from the rest of the blood taken for examinations.

Chronic Hepatitis B; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being followed up with a diagnosis of chronic hepatitis B
• Not having a known history of liver disease who applied to our outpatient clinic for other reasons
• Having a liver biopsy
• ≥18 years

You may not qualify if:

• \<18 years

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (2)

• Wei X, Yu H, Zhao P, Xie L, Li L, Zhang J. Serum regucalcin is a useful indicator of liver injury severity in patients with hepatitis B virus-related liver diseases. Braz J Med Biol Res. 2019 Sep 30;52(10):e8845. doi: 10.1590/1414-431X20198845. eCollection 2019.

  PMID: 31576907 BACKGROUND

• Yamaguchi M, Isogai M, Shimada N. Potential sensitivity of hepatic specific protein regucalcin as a marker of chronic liver injury. Mol Cell Biochem. 1997 Feb;167(1-2):187-90. doi: 10.1023/a:1006859121897.

  PMID: 9059996 BACKGROUND

MeSH Terms

Conditions

Hepatitis B, Chronic; Liver Cirrhosis; Hepatitis B; Fibrosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients undergoing liver biopsy for chronic hepatitis b

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: June 28, 2022
• Study Start: August 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 1, 2021
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)