Clinical trial NCT06836518: Sialic Acid in Hepatocellular Carcinoma
Official title: Serum Sialic Acid as a Novel Biomarker in the Diagnosis of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Serum Sialic Acid
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: