Serum Visfatin and Serum Vaspin in Patients With Hepatocellular Carcinoma on Top of Liver Cirrhosis

NCT04763707 | Completed DMC

• 1 other identifier: Soh-Med-21-02-04
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) has a global importance due to its high rate of progression and high mortality rates. Significant risk factors for the development of HCC are metabolic syndrome, obesity and type 2 diabetes mellitus(T2DM). Dysregulation of adipose tissue derived hormones(adipocytokines/adipokines) might also be involved in obesity-related liver carcinogenesis \& due to the wide spectrum of visfatin and vaspin activities ,we focus in this study on their potential role in patients with HCV-related liver cirrhosis with and without HCC on top.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• serum Visfatin & serum Vaspin levels

  The 2 markers will be measured in the 3 groups , compared with each one \& asses if they are valuable as diagnostic markers for HCC , staging HCC , chronic liver diseases \& Metabolic disorders.

  they are measured once in all groups then compared after collection of samples, this will be in average 1.5 years

Study Arms (3)

Group 1 : Hepatocellular carcinoma HCC patients with HCV

40 HCV-related liver cirrhosis patients with HCC on top (Group 1).

Group 2 : Cirrhotic patients with HCV

30 HCV-related liver cirrhosis patients(Group 2).

Group 3 : Healthy control

20 healthy volunteers will be included as controls(Group 3).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 70 patients with HCV-related liver cirrhosis attending the outpatient clinic or inpatient section of the department will be included in the study, patients will be categorized into 2 groups: * 40 HCV-related liver cirrhosis patients with HCC on top (Group 1). * 30 HCV-related liver cirrhosis patients(Group 2). * In addition, 20 healthy volunteers will be included as controls(Group 3).

You may qualify if:

• The diagnosis of CHC will be based on positive HCV antibodies by enzyme-linked immunosorbent assay(ELIZA)\& HCV RNA by Polymerase chain reaction ( PCR) for more than 6 months. The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of HCC will be based on the typical features of dynamic imaging by triphasic CT with or without elevated serum alpha-fetoprotein (AFP) .

You may not qualify if:

• \- Co-infection with HBV.
• Presence of clinically suspected other causes of hepatocellular injury ( any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Wilson's disease, fatty liver disases with metabolic syndrome \&drug induced liver disease.
• Patients diagnosed with other malignancies.
• Patients with history of prior local or systemic HCC-specific treatment.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine

Sohag, 82524, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample of each participant

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Khairy Hammam Morsy, Professor

  Sohag University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diagnostic Accuracy of Serum Visfatin and Serum Vaspin in Patients with Hepatocellular Carcinoma on Top of Liver Cirrhosis

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: April 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

EG (1)