Hepatocellular CarcinomaNCT06836518
Sialic Acid in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Sohag University.
Trial summary
Hepatocellular carcinoma (HCC) accounts for approximately 90% of the cases of liver cancer and is associated with high morbidity and mortality. The increased sialic acids(SAs) in tumor cells are mainly caused by the special metabolic flux and aberrant expression of sialyltransferases/sialidases, The high sensitivity… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- serum sialic acid
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Adult, Older adult
Study population: The study will include normal persons, patients with liver cirrhosis and HCC patients attending to the outpatient clinic or inpatient section of the department of Tropical medicine and Gastroenterology and Radiological department at Sohag University Hospital will be included. HCC will be assessed by ultrasonography, alpha fetoprotein plus triphasic CT or MRI. Group I: The study group will include normal healthy persons who will be selected randomly. Group II: The study group will include patients diagnosed with liver cirrhosis with no detected hepatic focal lesion by ultrasound. Cirrhosis will be determined according to clinical, serological and radiological findings. Group III: The study group will include patients with liver cirrhosis and HCC. All causes of liver cirrhosis will be accepted. HCC will be assessed by triphasic CT or MRI.
Who may be able to join
- The study will include normal persons, patients with liver cirrhosis and HCC patients attending to the outpatient clinic or inpatient section of the department of Tropical medicine and Gastroenterology and Radiological department at Sohag University Hospital will be included.
Who cannot join
- 1- Patients aged < 18 or > 70 years. 2- Patients with other malignancy rather than HCC. 3- Patients with history of prior intervention or systemic chemotherapy for HCC.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mahmoud S Abd El fatah, Professor contact
About this study
Official title: Serum Sialic Acid as a Novel Biomarker in the Diagnosis of Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) accounts for approximately 90% of the cases of liver cancer and is associated with high morbidity and mortality.
The increased sialic acids(SAs) in tumor cells are mainly caused by the special metabolic flux and aberrant expression of sialyltransferases/sialidases, The high sensitivity of sialic acids in or plasma as a tumor marker has been reported in various cancerous conditions the level of sialic acid(SA) activity was found to offer highly specific and sensitive tumor biomarker for diagnosis and follow up of HCC post-therapy.
Read the detailed description
Liver cancer is a growing global health challenge, with an estimated annual incidence of >1 million cases worldwide by 2025.
Hepatocellular carcinoma (HCC) accounts for approximately 90% of the cases of liver cancer and is associated with high morbidity and mortality.
The most prominent risk factors for HCC include hepatitis B (HBV), hepatitis C (HCV) viral infections and non-alcoholic steatohepatitis (NASH), which can lead to liver fibrosis and cirrhosis.
Other risk factors include heavy alcohol consumption, non-alcoholic fatty liver disease (NAFLD), consumption of aflatoxins, obesity associated with metabolic syndrome, type 2 diabetes (T2D), and tobacco smoking.
Sialic acids (SAs) are a subset of nine carbon acidic sugars that contain approximately fifty derivatives of neuraminic acids. The most common sialic acid derivatives found in mammals are N-acetylneuraminic acid (Neu5Ac) and N-glycolylneuraminic acid (Neu5Gc).
Sialic acid (SA) structural diversity leads to many biological functions, including antiviral activity, antioxidant activity, anti-adhesion activity , anti-inflammatory property, and improving learning and memory, promoting bone growth and prebiotics .
SA can participate in important pathological and physiological processes and can be used as nutrition, drugs and drug carriers to prevent diseases. Therefore, SA is a promising active substance, which can improve human health.
SAs on tumor cell surfaces are aberrantly expressed during tumor transformation and malignant progression. In general, hypersialylation is frequently observed in tumor tissues compared to corresponding normal tissue.
The increased SAs in tumor cells are mainly caused by the special metabolic flux and aberrant expression of sialyltransferases/sialidases.
Abnormal expression of SA is atypical symbol of tumor cells. β-galactoside α2,6 sialyl transferases is closely related to tumorigenesis and tumor progression. High levels of β-galactoside α2,6-sialyltransferases mediated tumorigenesis and metastasis in HCC cells by activating the Wnt/β-catenin pathway.
The high sensitivity of SAs in serum or plasma as a tumor marker has been reported in various cancerous conditions. Quantification of total SAs or glycolipid-bound sialic acids in serum is helpful to improve the accuracy of clinical diagnoses and therapies.
The level of SA activity was found to offer highly specific and sensitive tumor biomarker for HCC diagnosis and follow up of HCC post-therapy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- serum sialic acid
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum sialic acidDiagnostic test
measurement of serum sialic acid to evaluate its efficacy in the diagnosis of hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| healthy persons | The study group will include normal healthy persons who will be selected randomly. Receives: Diagnostic Test: serum sialic acid | |
| cirrhotic patients | The study group will include patients diagnosed with liver cirrhosis with no detected hepatic focal lesion by ultrasound. Receives: Diagnostic Test: serum sialic acid | |
| cirrhotic patients with hepatocellular carcinoma | The study group will include patients with liver cirrhosis and hepatocellular carcinoma. All causes of liver cirrhosis will be accepted. HCC will be assessed by triphasic CT or MRI. Receives: Diagnostic Test: serum sialic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Sialic Acid
measurement of serum sialic acid concentration according to ELISA method to evaluate its diagnostic efficacy in hepatocellular carcinoma
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Khalifa Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836518
- Sponsor's protocol ID
- Soh-Med-25-2-1MD
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Sialic Acid as a Novel Biomarker in the Diagnosis of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06836518
- Acronym / sponsor ID
- Soh-Med-25-2-1MD
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 20 Feb 2025 (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) accounts for approximately 90% of the cases of liver cancer and is associated with high morbidity and mortality.
The increased sialic acids(SAs) in tumor cells are mainly caused by the special metabolic flux and aberrant expression of sialyltransferases/sialidases, The high sensitivity of sialic acids in or plasma as a tumor marker has been reported in various cancerous conditions the level of sialic acid(SA) activity was found to offer highly specific and sensitive tumor biomarker for diagnosis and follow up of HCC post-therapy.
Detailed description
Liver cancer is a growing global health challenge, with an estimated annual incidence of >1 million cases worldwide by 2025.
Hepatocellular carcinoma (HCC) accounts for approximately 90% of the cases of liver cancer and is associated with high morbidity and mortality.
The most prominent risk factors for HCC include hepatitis B (HBV), hepatitis C (HCV) viral infections and non-alcoholic steatohepatitis (NASH), which can lead to liver fibrosis and cirrhosis.
Other risk factors include heavy alcohol consumption, non-alcoholic fatty liver disease (NAFLD), consumption of aflatoxins, obesity associated with metabolic syndrome, type 2 diabetes (T2D), and tobacco smoking.
Sialic acids (SAs) are a subset of nine carbon acidic sugars that contain approximately fifty derivatives of neuraminic acids. The most common sialic acid derivatives found in mammals are N-acetylneuraminic acid (Neu5Ac) and N-glycolylneuraminic acid (Neu5Gc).
Sialic acid (SA) structural diversity leads to many biological functions, including antiviral activity, antioxidant activity, anti-adhesion activity , anti-inflammatory property, and improving learning and memory, promoting bone growth and prebiotics .
SA can participate in important pathological and physiological processes and can be used as nutrition, drugs and drug carriers to prevent diseases. Therefore, SA is a promising active substance, which can improve human health.
SAs on tumor cell surfaces are aberrantly expressed during tumor transformation and malignant progression. In general, hypersialylation is frequently observed in tumor tissues compared to corresponding normal tissue.
The increased SAs in tumor cells are mainly caused by the special metabolic flux and aberrant expression of sialyltransferases/sialidases.
Abnormal expression of SA is atypical symbol of tumor cells. β-galactoside α2,6 sialyl transferases is closely related to tumorigenesis and tumor progression. High levels of β-galactoside α2,6-sialyltransferases mediated tumorigenesis and metastasis in HCC cells by activating the Wnt/β-catenin pathway.
The high sensitivity of SAs in serum or plasma as a tumor marker has been reported in various cancerous conditions. Quantification of total SAs or glycolipid-bound sialic acids in serum is helpful to improve the accuracy of clinical diagnoses and therapies.
The level of SA activity was found to offer highly specific and sensitive tumor biomarker for HCC diagnosis and follow up of HCC post-therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy persons | – | Diagnostic Test: serum sialic acidThe study group will include normal healthy persons who will be selected randomly. |
| cirrhotic patients | – | Diagnostic Test: serum sialic acidThe study group will include patients diagnosed with liver cirrhosis with no detected hepatic focal lesion by ultrasound. |
| cirrhotic patients with hepatocellular carcinoma | – | Diagnostic Test: serum sialic acidThe study group will include patients with liver cirrhosis and hepatocellular carcinoma. All causes of liver cirrhosis will be accepted. HCC will be assessed by triphasic CT or MRI. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include normal persons, patients with liver cirrhosis and HCC patients attending to the outpatient clinic or inpatient section of the department of Tropical medicine and Gastroenterology and Radiological department at Sohag University Hospital will be included. HCC will be assessed by ultrasonography, alpha fetoprotein plus triphasic CT or MRI. Group I: The study group will include normal healthy persons who will be selected randomly. Group II: The study group will include patients diagnosed with liver cirrhosis with no detected hepatic focal lesion by ultrasound. Cirrhosis will be determined according to clinical, serological and radiological findings. Group III: The study group will include patients with liver cirrhosis and HCC. All causes of liver cirrhosis will be accepted. HCC will be assessed by triphasic CT or MRI.
Key inclusion criteria (1 listed)
- The study will include normal persons, patients with liver cirrhosis and HCC patients attending to the outpatient clinic or inpatient section of the department of Tropical medicine and Gastroenterology and Radiological department at Sohag University Hospital will be included.
Key exclusion criteria (1 listed)
- 1- Patients aged < 18 or > 70 years. 2- Patients with other malignancy rather than HCC. 3- Patients with history of prior intervention or systemic chemotherapy for HCC.
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 |
|---|---|---|
| serum sialic acidmeasurement of serum sialic acid to evaluate its efficacy in the diagnosis of hepatocellular carcinoma | Diagnostic test | cirrhotic patients, cirrhotic patients with hepatocellular carcinoma, healthy persons |
Primary outcome
Serum Sialic Acid
Time frame: one year
measurement of serum sialic acid concentration according to ELISA method to evaluate its diagnostic efficacy in hepatocellular carcinoma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- 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.
Mahmoud S Abd El fatah, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sohag University.
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 1 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: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman KH Al-Sayed, assistant lecturer (01064227870, emankhalifa6461@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Sialic Acid (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025.