Serum Regucalcin Level and Chronic Hepatitis B

Sponsor
Konya Meram State Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05435599
Collaborator
(none)
120
1
2
16
7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Serum regucalcin level
N/A

Detailed Description

Chronic hepatitis B (CHB) infection continues to be an important health problem due to its high morbidity and mortality. For this reason, it is very important to determine the appropriate timing to start antiviral therapy in patients with CHB infection and to evaluate the stage of liver fibrosis in the treatment follow-up. Liver biopsy is the gold standard for detecting liver fibrosis. Although it is generally accepted to be a safe procedure, it can cause some serious complications. For this reason, in recent years, many studies have been conducted on new noninvasive tests in the evaluation of liver fibrosis. One of them is the serum regucalcin level. Studies have shown that serum regucalcin levels increase in liver damage, but there is no study in the literature comparing liver fibrosis and serum regucalcin levels in CHB infection. This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients undergoing liver biopsy for chronic hepatitis bPatients undergoing liver biopsy for chronic hepatitis b
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Efficacy of Serum Regucalcin Level in Detecting Fibrosis in Chronic Hepatitis B Infection
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Chronic Hepatitis B

Measurement of serum regucalcin level

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

Other: Healthy Volunteers

Measurement of serum regucalcin level

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

Outcome Measures

Primary Outcome Measures

  1. Comparison of serum regucalcin levels with liver fibrosis levels [Performing liver biopsies: 3 months, data collection: 1 month, writing the article: 1 month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • <18 years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Konya Training and Research Hospital Konya Turkey 42090

Sponsors and Collaborators

  • Konya Meram State Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fatma Çölkesen, Principal Investigator, Konya Meram State Hospital
ClinicalTrials.gov Identifier:
NCT05435599
Other Study ID Numbers:
  • 10542
First Posted:
Jun 28, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatma Çölkesen, Principal Investigator, Konya Meram State Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2022