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

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05088811

Collaborator

(none)

Enrollment

Locations

12.4

Anticipated Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Liver Cirrhosis Diagnoses Disease	Diagnostic Test: WRAP53, UCA-1

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 21, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Liver cirrhosis

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

Diagnostic Test: WRAP53, UCA-1

Diagnostic value of UCA-1 and WRAP53 in HCC

Hepatocellular Carcinoma

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

Diagnostic Test: WRAP53, UCA-1

Diagnostic value of UCA-1 and WRAP53 in HCC

Control

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

Diagnostic Test: WRAP53, UCA-1

Diagnostic value of UCA-1 and WRAP53 in HCC

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Any subject without any of the exclusion criteria

Exclusion Criteria:

Patients with any inflammatory diseases or other malignancies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria University, faculty of medicine	Alexandria		Egypt	21311
2	Alexandria University, medical research institute	Alexandria		Egypt	21561

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elsheaita, Ahmed Mohamed Elmoughazy Abdelfatah Aly, Assistant lecturer, experimental and clinical internal medicine, medical research institute, Alexandria University

ClinicalTrials.gov Identifier:

NCT05088811

Other Study ID Numbers:

HCC medical research institute

First Posted:

Oct 22, 2021

Last Update Posted:

Oct 22, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elsheaita, Ahmed Mohamed Elmoughazy Abdelfatah Aly, Assistant lecturer, experimental and clinical internal medicine, medical research institute, Alexandria University

Hcc, liver cirrhosis, UCA-1, WRAP53

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Liver Cirrhosis

Disease

Fibrosis

Study Results

No Results Posted as of Oct 22, 2021