Clinical trial NCT04763707: Serum Visfatin and Serum Vaspin in Patients With Hepatocellular Carcinoma on Top of Liver Cirrhosis
Official title: Diagnostic Accuracy of Serum Visfatin and Serum Vaspin in Patients With Hepatocellular Carcinoma on Top of Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

Detailed description: Despite improvements in HCC therapy, the prognosis for HCC patients remains poor due to a high incidence of recurrence. Early diagnosis can significantly improve the overall survival of HCC patients. However, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker alpha-fetoprotein (AFP) has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC.

As such, AFP has been excluded from being a marker for the diagnosis of HCC by Practice Guidelines of the American Association for the study of Liver Diseases (AASLD) and confirmed by other studies.

These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. An improved understanding of the pathogenesis of HCC development would facilitate the development of more effective outcomes for the diagnosis and treatment of HCC at earlier stages.

Eligibility criteria: Inclusion Criteria:

* 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) .

Exclusion Criteria:

* - 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.

Primary outcomes:
measure: serum Visfatin & serum Vaspin levels
timeFrame: they are measured once in all groups then compared after collection of samples, this will be in average 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Sohag University
name: Khairy Hammam Morsy, Professor
role: STUDY_DIRECTOR
References: