Sialic Acid in Hepatocellular Carcinoma

NCT06836518 | Not Yet Recruiting

• 1 other identifier: Soh-Med-25-2-1MD
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Serum Sialic Acid

  measurement of serum sialic acid concentration according to ELISA method to evaluate its diagnostic efficacy in hepatocellular carcinoma

  one year

Study Arms (3)

healthy persons

The study group will include normal healthy persons who will be selected randomly.

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.

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.

Diagnostic Test: serum sialic acid

Interventions

serum sialic acid DIAGNOSTIC_TEST

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

cirrhotic patients; cirrhotic patients with hepatocellular carcinoma; healthy persons

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Eman KH Al-Sayed, assistant lecturer

CONTACT

01064227870; emankhalifa6461@gmail.com

Mahmoud S Abd El fatah, Professor

CONTACT

01091055908

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Tropical Medicine and Gastroenterology, Faculty of Medicine, Sohag University

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02