Serum Levels of Some Trace Elements in Hepatocellular Carcinoma Patients

Hepatocellular Carcinoma Clinical Trial

Official title:

Serum Levels of Some Trace Elements in Hepatocellular Carcinoma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488587
• Other study ID #: Soh-Med-22-07-11
• Status: Recruiting
• Start date: August 2022
• Est. completion date: August 2023

Study information

• Verified date: August 2022
• Source: Sohag University
• Contact: Ahmed A Ibrahim, Residant
• Phone: 01008444278
• Email: ahmedatef8444[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• magnesium and zinc levels
measuring magnesium and zinc levels

Locations

Country	Name	City	State
Egypt	Sohag university hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Al Alawi AM, Majoni SW, Falhammar H. Magnesium and Human Health: Perspectives and Research Directions. Int J Endocrinol. 2018 Apr 16;2018:9041694. doi: 10.1155/2018/9041694. eCollection 2018. Review. — View Citation

Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Piñeros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. [Epub ahead of print] — View Citation

Huang WQ, Long WQ, Mo XF, Zhang NQ, Luo H, Lin FY, Huang J, Zhang CX. Direct and indirect associations between dietary magnesium intake and breast cancer risk. Sci Rep. 2019 Apr 8;9(1):5764. doi: 10.1038/s41598-019-42282-y. — View Citation

Meng Y, Sun J, Yu J, Wang C, Su J. Dietary Intakes of Calcium, Iron, Magnesium, and Potassium Elements and the Risk of Colorectal Cancer: a Meta-Analysis. Biol Trace Elem Res. 2019 Jun;189(2):325-335. doi: 10.1007/s12011-018-1474-z. Epub 2018 Aug 31. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of Magnesium in cirrhotic patients and HCC	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.	12 months
Primary	Serum level of Zinc in cirrhotic patients and HCC	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.	12 months
Secondary	serum level of Magnesium and the Barcelona clinic classification	To investigate the relationship between serum level of Magnesium and the Barcelona Clinic Liver Cancer (BCLC) stage of HCC.	12 months
Secondary	serum level of Zinc and the Barcelona clinic classification	To investigate the relationship between serum level of Zinc and the Barcelona Clinic Liver Cancer (BCLC) stage of HCC.	12 months