Non-B Non-C Liver CirrhosisNCT05314270
Evaluation of Non-B Non-C Liver Cirrhosis in A EL-Rajhi Assuit University Hospital: A Retrospective-Prospective Study
An observational study of Non-B Non-C Liver Cirrhosis, run by Assiut University.
Trial summary
To study the etiologies of patients diagnosed as non-B, non-C liver cirrhosis (NBNC-LC). To describe the different patient's outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-B Non-C Liver Cirrhosis
- What is being tested?
- Diagnostic tests
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Nov 2023
- 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
- Child, Adult, Older adult
Study population: All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023
Who may be able to join
- All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023
Who cannot join
- We will exclude the pateints that will be diagnosed as HBV-HCV induced Liver Cirrosis
Trial locations and contacts
No sites are listed yet.
About this study
To study the etiologies of patients diagnosed as non-B, non-C liver cirrhosis (NBNC-LC).
To describe the different patient's outcomes.
Read the detailed description
Liver cirrhosis is the ultimate fate of many hepatic insults that may be viral, immunologic, and metabolic or even cryptogenic. (Tsochatzis EA et al., 2014)
Recently, Non-Alcoholic Fatty Liver Disease (NAFLD) present a serious health burden worldwide that affects around 25% of the global adult population with a prevalence of around 31.8% in the Middle East. (Younossi ZM, et al., 2019)
Most of Egyptian patients presented with end-stage liver disease are secondary to post-hepatitic cirrhosis is estimated to be more than 80% of cases. (Guerra J et al., 2012)
The real profile of non-B, non-C etiologies of liver cirrhosis, in Egyptian patients, is still not fully evaluated.
- Conditions
- Non-B Non-C Liver Cirrhosis
- Being tested
- Diagnostic tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testsDiagnostic test
Also called 24h copper in urine.. Iron profile.. Liver biopsy
Diaagnostic tests for all pt diagnosed as Non-B Non-C Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of different etiologies of liver cirrhosis that not related to HBV or HCV in our community
Measured: Base line
Secondary outcomes (1)
Detection of the most common etiologies of Non B Non C liver cirrhosis in our community
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-B Non-C Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut 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 only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman mohammed abdelrahman morsi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314270
- Sponsor's protocol ID
- Non-B Non-C Liver cirrhosis
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-B Non-C Liver Cirrhosis in A EL-Rajhi Assuit University Hospital: A Retrospective-Prospective Study
- ClinicalTrials.gov ID
- NCT05314270
- Acronym / sponsor ID
- Non-B Non-C Liver cirrhosis
- Conditions
- Non-B Non-C Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 6 Apr 2022 (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.
To study the etiologies of patients diagnosed as non-B, non-C liver cirrhosis (NBNC-LC).
To describe the different patient's outcomes.
Detailed description
Liver cirrhosis is the ultimate fate of many hepatic insults that may be viral, immunologic, and metabolic or even cryptogenic. (Tsochatzis EA et al., 2014)
Recently, Non-Alcoholic Fatty Liver Disease (NAFLD) present a serious health burden worldwide that affects around 25% of the global adult population with a prevalence of around 31.8% in the Middle East. (Younossi ZM, et al., 2019)
Most of Egyptian patients presented with end-stage liver disease are secondary to post-hepatitic cirrhosis is estimated to be more than 80% of cases. (Guerra J et al., 2012)
The real profile of non-B, non-C etiologies of liver cirrhosis, in Egyptian patients, is still not fully evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023
Key inclusion criteria (1 listed)
- All pateints diagnosed as Non-B Non-C Liver Cirrhosis in the period from 2017_2023
Key exclusion criteria (1 listed)
- We will exclude the pateints that will be diagnosed as HBV-HCV induced Liver Cirrosis
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 |
|---|---|---|
| Diagnostic testsAlso: 24h copper in urine.. Iron profile.. Liver biopsyDiaagnostic tests for all pt diagnosed as Non-B Non-C Liver Cirrhosis | Diagnostic test | – |
Primary outcome
Detection of different etiologies of liver cirrhosis that not related to HBV or HCV in our community
Time frame: Base line
1 secondary outcome
Detection of the most common etiologies of Non B Non C liver cirrhosis in our community
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Related trials for Non-B Non-C Liver Cirrhosis
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
RecruitingPhase 2
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
Cirrhosis, Cirrhosis, Liver
Active, not recruitingObservational study
Liver Cirrhosis Network Cohort Study
Cirrhosis, Cirrhosis, Liver
Active, not recruitingObservational study
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
Hepatocellular Carcinoma (HCC)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-B Non-C Liver Cirrhosis, run by Assiut University.
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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Abdelrahman Mohammed Abdelrahman Morsi (01140530170, bdalrhmnmrsy702@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of different etiologies of liver cirrhosis that not related to HBV or HCV in our community (time frame: Base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022.