Clinical trial NCT06328283: The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients
Official title: The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of GLutamine Synthetase and BCLAF1 in Diagnosis of Hepatocellular in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: - A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups:

Group I:

The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion

Group II:

The study group will include 45 patient with HCC on top of liver cirrhosis .

Brief summary: Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.

HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015).


Eligibility criteria: Inclusion Criteria:

* A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups:

Group I:

The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion as control group. Cirrhosis will be determined according to clinical , sereological ,radiological findings.

Group II:

The study group will include 45 patient with HCC on top of liver cirrhosis .All causes of liver cirrhosis will be accepted .HCC will be assessed by triphasic CT or MRI or histological validation .In these group we will take patients with liver cirrhosis with early hepatocellular carcinoma that defined as tumors smaller than 3cm and three or fewer in number at stage A according to BCLC staging also sometimes it includes solitary tumors up to 5 cm in size as defined in the Milan criteria. Both very early and early stage tumors are relatively small but both are hyper vascular in arterial phase.

Exclusion Criteria:

1. Non cirrhotic patients.
2. Patients with distant metastasis.
3. Patients aged below18 years.
4. Patients with other malignancy rather than HCC.
5. Patients with late stage of HCC.

Primary outcomes:
measure: glutamine synthetase
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
state: Sohagm
Study officials:
References:
citation: Mir IH, Guha S, Behera J, Thirunavukkarasu C. Targeting molecular signal transduction pathways in hepatocellular carcinoma and its implications for cancer therapy. Cell Biol Int. 2021 Nov;45(11):2161-2177. doi: 10.1002/cbin.11670. Epub 2021 Aug 1.
citation: Singh G, Yoshida EM, Rathi S, Marquez V, Kim P, Erb SR, Salh BS. Biomarkers for hepatocellular cancer. World J Hepatol. 2020 Sep 27;12(9):558-573. doi: 10.4254/wjh.v12.i9.558.
citation: Terentiev AA, Moldogazieva NT. Alpha-fetoprotein: a renaissance. Tumour Biol. 2013 Aug;34(4):2075-91. doi: 10.1007/s13277-013-0904-y. Epub 2013 Jun 14.
citation: Wasfy RE, Shams Eldeen AA. Roles of Combined Glypican-3 and Glutamine Synthetase in Differential Diagnosis of Hepatocellular Lesions. Asian Pac J Cancer Prev. 2015;16(11):4769-75. doi: 10.7314/apjcp.2015.16.11.4769.