The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients

NCT06328283 | Not Yet Recruiting

• 1 other identifier: Soh-Med-24-02-01MD
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• glutamine synthetase

  to detect early HCC IN CIRRHOTIC

  1 year

Study Arms (2)

cases group

cirrhotic patients with early hepatocellular carcinoma

Other: measure of Glutamine synthetase and BCLFAF1

control group

cirrhotic patients with no hepatocellular carcinoma

Other: measure of Glutamine synthetase and BCLFAF1

Interventions

measure of Glutamine synthetase and BCLFAF1 OTHER

compare Glutamine synthetase and BCLFAF1 in cases and controls

cases group; control group

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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.

You may not qualify if:

• Non cirrhotic patients.
• Patients with distant metastasis.
• Patients aged below18 years.
• Patients with other malignancy rather than HCC.
• Patients with late stage of HCC.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Sohagm, Egypt

Location

Related Publications (4)

• 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.

  PMID: 34270844 BACKGROUND

• 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.

  PMID: 33033565 BACKGROUND

• 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.

  PMID: 23765762 BACKGROUND

• 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.

  PMID: 26107238 BACKGROUND

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

Central Study Contacts

Esraa s ABDELRHMAN, assistant lecutrer

CONTACT

01000496350; esraa.ahmed1@med.sohag.eg

mahmoud s el eslam, professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer in tropical medicine- sohag university

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

EG (1)