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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Hepatocellular Carcinoma; Diagnoses Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Ahmed Elsheaita, Msc; Phone Number: +201062099085; Email: A_mohamed200690@alexmed.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21311
    • Recruiting
    • Alexandria university, Faculty of medicine
    • Contact: Amira Eid, MD; Email: Amira.eid@alexmed.edu.eg
  • Alexandria, Egypt, 21561
    • Recruiting
    • Alexandria University, medical research institute
    • Contact: Amal Ghanem, MD; Email: mri-dean@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Any subject without any of the exclusion criteria

Exclusion Criteria:

• Patients with any inflammatory diseases or other malignancies.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• Kamel MM, Matboli M, Sallam M, Montasser IF, Saad AS, El-Tawdi AHF. Investigation of long noncoding RNAs expression profile as potential serum biomarkers in patients with hepatocellular carcinoma. Transl Res. 2016 Feb;168:134-145. doi: 10.1016/j.trsl.2015.10.002. Epub 2015 Oct 24.
• Pouladi N, Abdolahi S, Farajzadeh D, Hosseinpour Feizi MA. Haplotype and linkage disequilibrium of TP53-WRAP53 locus in Iranian-Azeri women with breast cancer. PLoS One. 2019 Aug 6;14(8):e0220727. doi: 10.1371/journal.pone.0220727. eCollection 2019.
• Wang F, Ying HQ, He BS, Pan YQ, Deng QW, Sun HL, Chen J, Liu X, Wang SK. Upregulated lncRNA-UCA1 contributes to progression of hepatocellular carcinoma through inhibition of miR-216b and activation of FGFR1/ERK signaling pathway. Oncotarget. 2015 Apr 10;6(10):7899-917. doi: 10.18632/oncotarget.3219.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 9, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Hcc, liver cirrhosis, UCA-1, WRAP53
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Fibrosis; Carcinoma; Disease; Carcinoma, Hepatocellular; Liver Cirrhosis
• Other Study ID Numbers: HCC medical research institute

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