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NCT Number: NCT06836518

Sialic Acid in 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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

serum sialic acid

Diagnostic Test

measurement of serum sialic acid to evaluate its efficacy in the diagnosis of hepatocellular carcinoma

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eman KH Al-Sayed, assistant lecturer

CONTACT

[email protected]

01064227870

Mahmoud S Abd El fatah, Professor

CONTACT

01091055908

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Serum Sialic Acid as a Novel Biomarker in the Diagnosis of Hepatocellular Carcinoma

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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