Hepatocellular CarcinomaNCT05488587
Serum Levels of Some Trace Elements in Hepatocellular Carcinoma Patients
An observational study of Hepatocellular Carcinoma, run by Sohag University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- magnesium and zinc levels
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2022to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults of both genders with compensated or decompensated liver cirrhosis with or without HCC.
Who may be able to join
- Adults (≥18 years old) of both genders with compensated or decompensated liver cirrhosis with or without HCC.
Who cannot join
- Patients who received Zn or Mg supplementation within the previous 3 months.
- Non-cirrhotic HCC
- Patients with other malignancies.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
Mahmoud S El-Islam, assitant Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Osama R Elsherif, professor
About this study
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 .
Read the 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 .
- Conditions
- Hepatocellular Carcinoma
- Being tested
- magnesium and zinc levels
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium and zinc levelsDiagnostic test
measuring magnesium and zinc levels
| Study group | Role | What they receive |
|---|---|---|
| hepatocellular carcinoma | Not described Receives: Diagnostic Test: magnesium and zinc levels | |
| liver cirrhosis | Not described Receives: Diagnostic Test: magnesium and zinc levels | |
| healthy individuals | Not described Receives: Diagnostic Test: magnesium and zinc levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Atef Fadel Ibrahem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488587
- Sponsor's protocol ID
- Soh-Med-22-07-11
- Status last verified
- Aug 2022
- First submitted
- 19 Jul 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29849626Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Pineros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. Online ahead of print.
PubMed 33818764Huang 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.
PubMed 30962499Meng 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.
PubMed 30171595
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Some Trace Elements in Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT05488587
- Acronym / sponsor ID
- Soh-Med-22-07-11
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hepatocellular carcinoma | – | Diagnostic Test: magnesium and zinc levels |
| liver cirrhosis | – | Diagnostic Test: magnesium and zinc levels |
| healthy individuals | – | Diagnostic Test: magnesium and zinc levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults of both genders with compensated or decompensated liver cirrhosis with or without HCC.
Key inclusion criteria (1 listed)
- Adults (≥18 years old) of both genders with compensated or decompensated liver cirrhosis with or without HCC.
Key exclusion criteria (4 listed)
- Patients who received Zn or Mg supplementation within the previous 3 months.
- Non-cirrhotic HCC
- Patients with other malignancies.
- Pregnant and lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium and zinc levelsmeasuring magnesium and zinc levels | Diagnostic test | healthy individuals, hepatocellular carcinoma, liver cirrhosis |
Primary outcome
Serum levels of Magnesium in cirrhotic patients and HCC
Time frame: 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
Time frame: 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.
2 secondary outcomes
serum level of Magnesium and the Barcelona clinic classification
Time frame: 12 months
serum level of Zinc and the Barcelona clinic classification
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 29849626Al 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.
- Background: PubMed 33818764Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Pineros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. Online ahead of print.
- Background: PubMed 30962499Huang 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.
- Background: PubMed 30171595Meng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud S El-Islam, assitant Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Ibrahim, Residant (01008444278, ahmedatef8444@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of Magnesium in cirrhotic patients and HCC (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488587, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.