Hepatocellular CarcinomaNCT05088811
The Role of Long Non-coding RNAs WRAP53 and UCA-1 as Potential Biomarkers in Diagnosis of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Alexandria University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis, Diagnoses Disease
- What is being tested?
- WRAP53, UCA-1
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 21 Aug 2021to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Any subject without any of the exclusion criteria
Who cannot join
- Patients with any inflammatory diseases or other malignancies.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Alexandria University, faculty of medicine
Alexandria, 21311
Amira Eid, MD, Amira.eid@alexmed.edu.eg
- Recruiting
Alexandria University, medical research institute
Alexandria, 21561
Amal Ghanem, MD, mri-dean@alexu.edu.eg
About this study
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Diagnoses Disease
- Being tested
- WRAP53, UCA-1
- Keywords
- Hcc, liver cirrhosis, UCA-1, WRAP53
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WRAP53, UCA-1Diagnostic test
Diagnostic value of UCA-1 and WRAP53 in HCC
| Study group | Role | What they receive |
|---|---|---|
| Liver cirrhosis | Group (1): Thirty patients having liver cirrhosis and hepatocellular carcinoma diagnosed by tripahsic CT. Receives: Diagnostic Test: WRAP53, UCA-1 | |
| Hepatocellular Carcinoma | Group (2): Thirty liver cirrhosis patients without hepatocellular carcinoma diagnosed by abdominal ultrasound examination Receives: Diagnostic Test: WRAP53, UCA-1 | |
| Control | Group (3): Twenty normal subjects (control group) matching in age and sex with patients in groups 1 and 2. Receives: Diagnostic Test: WRAP53, UCA-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start21 Aug 2021
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsheaita, Ahmed Mohamed Elmoughazy Abdelfatah Aly, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088811
- Sponsor's protocol ID
- HCC medical research institute
- Status last verified
- Oct 2021
- First submitted
- 21 Aug 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26551349Pouladi 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.
PubMed 31387111Wang 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.
PubMed 25760077Abdelmoety AA, Elhassafy MY, Said RSO, Elsheaita A, Mahmoud MM. The role of UCA1 and WRAP53 in diagnosis of hepatocellular carcinoma: A single-center case-control study. Clin Exp Hepatol. 2023 Jun;9(2):129-137. doi: 10.5114/ceh.2023.127569. Epub 2023 Jun 18.
PubMed 37502440
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Long Non-coding RNAs WRAP53 and UCA-1 as Potential Biomarkers in Diagnosis of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05088811
- Acronym / sponsor ID
- HCC medical research institute
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Diagnoses Disease
- Keywords
- Hcc, liver cirrhosis, UCA-1, WRAP53
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liver cirrhosis | – | Diagnostic Test: WRAP53, UCA-1Group (1): Thirty patients having liver cirrhosis and hepatocellular carcinoma diagnosed by tripahsic CT. |
| Hepatocellular Carcinoma | – | Diagnostic Test: WRAP53, UCA-1Group (2): Thirty liver cirrhosis patients without hepatocellular carcinoma diagnosed by abdominal ultrasound examination |
| Control | – | Diagnostic Test: WRAP53, UCA-1Group (3): Twenty normal subjects (control group) matching in age and sex with patients in groups 1 and 2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Any subject without any of the exclusion criteria
Key exclusion criteria (1 listed)
- Patients with any inflammatory diseases or other malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WRAP53, UCA-1Diagnostic value of UCA-1 and WRAP53 in HCC | Diagnostic test | Control, Hepatocellular Carcinoma, Liver cirrhosis |
Primary outcome
Diagnostic value of long non coding RNA UCA-1 and WRAP53 in Hepatolcellular carcinoma
Time frame: One year
Calculating sensitivity and specifity of UCA-1 and WRAP53 to assess their diagnostic value in diagnosis of hepatocellular carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Results publication: PubMed 26551349Kamel 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.
- Results publication: PubMed 31387111Pouladi 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.
- Results publication: PubMed 25760077Wang 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.
- Derived from this study: PubMed 37502440Abdelmoety AA, Elhassafy MY, Said RSO, Elsheaita A, Mahmoud MM. The role of UCA1 and WRAP53 in diagnosis of hepatocellular carcinoma: A single-center case-control study. Clin Exp Hepatol. 2023 Jun;9(2):129-137. doi: 10.5114/ceh.2023.127569. Epub 2023 Jun 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Cirrhosis, run by Alexandria University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Elsheaita, Msc (+201062099085, A_mohamed200690@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of long non coding RNA UCA-1 and WRAP53 in Hepatolcellular carcinoma (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05088811, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.