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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine

Sohag, 82524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

serum Visfatin & serum Vaspin levels

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

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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Feb 21, 2021
Registry last updated: Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed