Clinical trial NCT05088811: The Role of Long Non-coding RNAs WRAP53 and UCA-1 as Potential Biomarkers in Diagnosis of Hepatocellular Carcinoma
Official title: The Role of Long Non-coding RNAs WRAP53 and UCA-1 as Potential Biomarkers in Diagnosis of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Liver Cirrhosis
Diagnoses Disease
Keywords: Hcc, liver cirrhosis, UCA-1, WRAP53
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Any subject without any of the exclusion criteria

Exclusion Criteria:

* Patients with any inflammatory diseases or other malignancies.

Primary outcomes:
measure: Diagnostic value of long non coding RNA UCA-1 and WRAP53 in Hepatolcellular carcinoma
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, faculty of medicine
city: Alexandria
country: Egypt
facility: Alexandria University, medical research institute
Study officials:
References:
citation: 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.
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.
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(10):7899-917. doi: 10.18632/oncotarget.3219.