TAURINE and HCC PATIENTS

COMPARISON BETWEEN SERUM TAURINE AND SPECIFIC TUMOR MARKERS FOR EARLY DETECTION AND DIAGNOSIS OF HCC IN EGYPTIAN PATIENTS

Serum taurine level beside (AFP and AFU) are of great value in early diagnosis in HCC Egyptian patients and may have a rule in identifying end-stage liver disease (ESLD) patients candidate for LDLT.

Study Overview

• Status: Completed
• Conditions: Taurine in HCC
• Intervention / Treatment: Diagnostic test: taurine level

Detailed Description

Taurine has been demonstrated to have a direct and indirect antioxidant effect and to display antineoplastic activity by preventing angiogenesis and enhancing tumor cell apoptosis. Also it was suggested that measurement of serum taurine level in hepatic patients beside fibroscan is of great value in the early diagnosis of any fibrotic and cancerous liver changes.Aim of the work was to correlate serum taurine level with the levels of the specific tumor markers (α- fetoprotein and α-L-fucosidase ) for early diagnosis of different stages of HCC in Egyptian patients.

This observational case-control study was conducted in the Tropical Medicine Department, Ahmed Maher Teaching Hospital. Eighty hepatic patients were assigned to three groups (Chronic hepatitis, Cirrhosis and HCC). Twenty healthy subjects were enrolled as a control group. Serum levels of AFP, AFU, and taurine beside complete biochemical analysis and liver biopsies from all selected patients were done. Patients who accepted to be a candidate for living donor liver transplant (LDLT) were referred to Ain Shams University Specialized Hospital (ASUSH) liver transplant unit.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ain Shams University Specialized Hospital
    • Cairo, Ain Shams University Specialized Hospital, Egypt
      • Hanaa El Gendy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic hepatitis
• Cirrhosis
• HCC patients

Exclusion Criteria:

• Patient refusal
• Bleeding tendency
• Tense ascites
• Inability to obtain a liver biopsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Diagnostic test: taurine level; Taurine: determined by High-Performance Liquid Chromatography according to the pre-column extraction and derivatization methodology of McMahon et al. in the present work we use the Shimadzu, Japan HPLC model LC-10 AT.
Active Comparator: Chronic hepatitis	Diagnostic test: taurine level; Taurine: determined by High-Performance Liquid Chromatography according to the pre-column extraction and derivatization methodology of McMahon et al. in the present work we use the Shimadzu, Japan HPLC model LC-10 AT.
Active Comparator: Cirrhosis	Diagnostic test: taurine level; Taurine: determined by High-Performance Liquid Chromatography according to the pre-column extraction and derivatization methodology of McMahon et al. in the present work we use the Shimadzu, Japan HPLC model LC-10 AT.
Active Comparator: Hepatocellular carcinoma	Diagnostic test: taurine level; Taurine: determined by High-Performance Liquid Chromatography according to the pre-column extraction and derivatization methodology of McMahon et al. in the present work we use the Shimadzu, Japan HPLC model LC-10 AT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Taurine level among patients groups	8 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: December 7, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HAM00077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No