Serum Levels of Some Trace Elements in Hepatocellular Carcinoma Patients

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: magnesium and zinc levels

• Registration Number: NCT05488587
• Lead Sponsor: Sohag University

Brief Summary

Hepatocellular carcinoma (HCC) is the sixth most frequent malignancy worldwide, with an estimated 906,000 new cases and 830,000 deaths in 2020. It is also the third leading cause for cancer deaths, with 15% 5-year survival rate .

Diagnosis of HCC in cirrhotic patients is mainly based on non-invasive imaging techniques. Multiphasic computed tomography (CT) and dynamic contrast-enhanced magnetic resonance imaging (MRI) are the most sensitive imaging techniques for diagnosis of HCC. While the most common serologic marker for early screening of HCC is alpha-fetoprotein (AFP) .

Liver is the main site of trace elements metabolism, and their levels are affected by different causes of liver disease .

Detailed Description

Hepatocellular carcinoma (HCC) is the sixth most frequent malignancy worldwide, with an estimated 906,000 new cases and 830,000 deaths in 2020. It is also the third leading cause for cancer deaths , with 15% 5-year survival rate.

Diagnosis of HCC in cirrhotic patients is mainly based on non-invasive imaging techniques. Multiphasic computed tomography (CT) and dynamic contrast-enhanced magnetic resonance imaging (MRI) are the most sensitive imaging techniques for diagnosis of HCC. While the most common serologic marker for early screening of HCC is alpha-fetoprotein (AFP).

Liver is the main site of trace elements metabolism, and their levels are affected by different causes of liver disease. Zinc (Zn) is an essential trace element which is required for the function of numerous enzymatic molecules active in human cell metabolic pathways. Zn plays an important role in cell growth, differentiation, apoptosis, and metabolism, with more than 300 proteins that regulate cellular functions containing Zn-binding domains. Zn protects against carcinogenesis as it helps activation of deoxyribonucleic acid (DNA) repair enzymes. Also it is a component of superoxide dismutase, an enzyme that removes free radicals.

Zn deficiency was reported to be associated with increased liver fibrosis.and hepatitis C virus (HCV) related HCC. Zn deficiency is also associated with complications related to liver cirrhosis, such as sarcopenia and hepatic encephalopathy.

Magnesium (Mg), as a co-factor for up to 600 enzymes, has a fundamental role in many physiological and biochemical functions including cell proliferation, DNA repair and energy metabolism.

The available data indicate an opposite role of Mg in the oncology field. Many authors showed that a high content of Mg in the diet is associated with a lower incidence of gastric, colon and breast cancers. However, various data showed that the availability of Mg by cancerous tissues could be involved in the development and/or growth of tumors .

A little is known about the significance of Mg in liver disease. A negative association of primary liver cancer with dietary intake of Mg has been demonstrated .

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-07-19
• Status Verified: 2022-08
• Study Start: 2022-08
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-04
• Last Update Submitted: 2022-08-06
• Last Update Posted: 2022-08-09
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults (≥18 years old) of both genders with compensated or decompensated liver cirrhosis with or without HCC.

Read More

Exclusion Criteria

• Patients who received Zn or Mg supplementation within the previous 3 months.
• Non-cirrhotic HCC
• Patients with other malignancies.
• Pregnant and lactating women.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hepatocellular carcinoma	magnesium and zinc levels	-
liver cirrhosis	magnesium and zinc levels	-
healthy individuals	magnesium and zinc levels	-

Primary Outcome Measures

Name	Time	Method
Serum levels of Magnesium in cirrhotic patients and HCC	12 months	To evaluate the serum level of Magnesium in cirrhotic patients with HCC, and to compare it with the level in cirrhotic patients without HCC and in healthy subjects.
Serum level of Zinc in cirrhotic patients and HCC	12 months	To evaluate the serum level of Zinc in cirrhotic patients with HCC, and to compare it with the level in cirrhotic patients without HCC and in healthy subjects.

Secondary Outcome Measures

Name	Time	Method
serum level of Magnesium and the Barcelona clinic classification	12 months	To investigate the relationship between serum level of Magnesium and the Barcelona Clinic Liver Cancer (BCLC) stage of HCC.
serum level of Zinc and the Barcelona clinic classification	12 months	To investigate the relationship between serum level of Zinc and the Barcelona Clinic Liver Cancer (BCLC) stage of HCC.

Trial Locations

Locations (1)

Sohag university hospital; 🇪🇬 Sohag, Egypt