The Role of Long Non-coding RNAs WRAP53 and UCA-1 as Potential Biomarkers in Diagnosis of Hepatocellular Carcinoma

• Conditions: Hepatocellular Carcinoma; Liver Cirrhosis; Diagnoses Disease
• Interventions: Diagnostic Test: WRAP53, UCA-1

• Registration Number: NCT05088811
• Lead Sponsor: Alexandria University

Brief Summary

The aim of this work is to study the role of long non-coding RNAs WRAP53 and urothelial carcinoma-associated 1 (UCA1) as potential biomarkers in diagnosis of hepatocellular carcinoma.

Detailed Description

Sample size calculation was done in department of medical statistics, Medical Research Institute, Alexandria University and the total minimal sample size was calculated.

A prospective case control study will be conducted on 80 subjects divided into three groups:

Group (1): Thirty patients having liver cirrhosis and hepatocellular carcinoma diagnosed by tripahsic CT.

Group (2): Thirty liver cirrhosis patients without hepatocellular carcinoma diagnosed by abdominal ultrasound examination.

Group (3): Twenty normal subjects (control group) matching in age and sex with patients in groups 1 and 2.

Patients will be recruited from the outpatient clinics and inpatient wards of Alexandria Main University Hospital and Medical Research Institute Hospital. Full informed consent will be taken from the patients and approval of the ethical committee of the Faculty of Medicine will be fulfilled. Exclusion criteria: Patients with any inflammatory diseases or other malignancies.

Study Timeline

• Study Start: 2021-08-21
• Study First Submitted: 2021-08-21
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-09
• Last Update Submitted: 2021-10-09
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Any subject without any of the exclusion criteria

Exclusion Criteria

• Patients with any inflammatory diseases or other malignancies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatocellular Carcinoma	WRAP53, UCA-1	Group (2): Thirty liver cirrhosis patients without hepatocellular carcinoma diagnosed by abdominal ultrasound examination
Control	WRAP53, UCA-1	Group (3): Twenty normal subjects (control group) matching in age and sex with patients in groups 1 and 2.
Liver cirrhosis	WRAP53, UCA-1	Group (1): Thirty patients having liver cirrhosis and hepatocellular carcinoma diagnosed by tripahsic CT.

Primary Outcome Measures

Name	Time	Method
Diagnostic value of long non coding RNA UCA-1 and WRAP53 in Hepatolcellular carcinoma	One year	Calculating sensitivity and specifity of UCA-1 and WRAP53 to assess their diagnostic value in diagnosis of hepatocellular carcinoma

Trial Locations

Locations (2)

Alexandria University, medical research institute; 🇪🇬 Alexandria, Egypt

Alexandria University, faculty of medicine; 🇪🇬 Alexandria, Egypt