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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088811
• Other study ID #: HCC medical research institute
• Status: Recruiting
• Start date: August 21, 2021
• Est. completion date: September 2022

Study information

• Verified date: October 2021
• Source: Alexandria University
• Contact: Ahmed Elsheaita, Msc
• Phone: +201062099085
• Email: A_mohamed200690[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any subject without any of the exclusion criteria

Exclusion Criteria:

• Patients with any inflammatory diseases or other malignancies.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Diagnoses Disease
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

Diagnostic Test:
• WRAP53, UCA-1
Diagnostic value of UCA-1 and WRAP53 in HCC

Locations

Country	Name	City	State
Egypt	Alexandria University, faculty of medicine	Alexandria
Egypt	Alexandria University, medical research institute	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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 — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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