TAURINE and HCC PATIENTS

NCT ID: NCT04193761

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-17

Study Completion Date

2018-10-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Taurine in HCC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

taurine level

Intervention Type DIAGNOSTIC_TEST

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.

Chronic hepatitis

Group Type ACTIVE_COMPARATOR

taurine level

Intervention Type DIAGNOSTIC_TEST

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.

Cirrhosis

Group Type ACTIVE_COMPARATOR

taurine level

Intervention Type DIAGNOSTIC_TEST

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.

Hepatocellular carcinoma

Group Type ACTIVE_COMPARATOR

taurine level

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis
* Cirrhosis
* HCC patients

Exclusion Criteria

* Patient refusal
* Bleeding tendency
* Tense ascites
* Inability to obtain a liver biopsy
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Hanaa Mohamed Abdallah ElGendy MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HAM00077

Identifier Type: -

Identifier Source: org_study_id