CirrhosisNCT02132351
Hepatic Fibrosis Non-invasive Methods Questionnaire
An observational study of Cirrhosis and Fibrosis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- How many people
- 717 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2013to Apr 2016
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatologists
Who may be able to join
- hepatologists
Who cannot join
- Non hepatologists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability, Reliability and Applicability of Liver Biopsy and Noninvasive Methods for Assessment of Hepatic Fibrosis and Cirrhosis Among Hepatologists; a Web Based Survey
Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.
Read the detailed description
Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.
Methods:
The study is a survey study among hepatologists. Four thousand hepatologists will be invited to participate in the questionnaire through e-mail invitations to answer 50 questions of the questionnaire. The questionnaire will be hosted on Survey monkey website and results will be analyzed to get the consensus opinion of participants for the use of invasive and non-invasive methods for assessment of hepatic fibrosis and cirrhosis and factors affecting their preferences.
Statistical analysis plan Analysis of data will be performed using Statistical Package for Scientific Studies 17 for Windows. Description of qualitative variables will be in the form of numbers (No.) and percent (%). Description of quantitative variables will be in the form of mean, standard deviation (SD). Questionnaire results will be compared against different baseline characteristics of the studied group. According to the type and distribution of data, suitable tests for inferential statistics will be used. Significance of the results will be presented in the form of P-value.
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatologists | Doctors working as hepatologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic fibrosis
Percentage of hepatologists accepting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
Measured: 3 years
Secondary outcomes (3)
Trust in non-invasive methods
Percentage of hepatologists trusting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
Measured: 3 years
use of non-invasive methods
Percentage of hepatologists who use invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
Measured: 3 years
combining non-invasive methods
Percentage of hepatologists combining different non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startAug 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alboraie, Al-Azhar University
- Investigators
- Mohamed Alboraie, M.Sc, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132351
- Sponsor's protocol ID
- MB-1
- Other IDs
- AlazharU-MB-1
- Status last verified
- Apr 2016
- First submitted
- 5 May 2014
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Reliability and Applicability of Liver Biopsy and Noninvasive Methods for Assessment of Hepatic Fibrosis and Cirrhosis Among Hepatologists; a Web Based Survey
- ClinicalTrials.gov ID
- NCT02132351
- Acronym / sponsor ID
- MB-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 May 2014 (estimated)
- 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.
Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.
Detailed description
Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.
Methods:
The study is a survey study among hepatologists. Four thousand hepatologists will be invited to participate in the questionnaire through e-mail invitations to answer 50 questions of the questionnaire. The questionnaire will be hosted on Survey monkey website and results will be analyzed to get the consensus opinion of participants for the use of invasive and non-invasive methods for assessment of hepatic fibrosis and cirrhosis and factors affecting their preferences.
Statistical analysis plan Analysis of data will be performed using Statistical Package for Scientific Studies 17 for Windows. Description of qualitative variables will be in the form of numbers (No.) and percent (%). Description of quantitative variables will be in the form of mean, standard deviation (SD). Questionnaire results will be compared against different baseline characteristics of the studied group. According to the type and distribution of data, suitable tests for inferential statistics will be used. Significance of the results will be presented in the form of P-value.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatologists | – | –Doctors working as hepatologists |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatologists
Key inclusion criteria (1 listed)
- hepatologists
Key exclusion criteria (1 listed)
- Non hepatologists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hepatic fibrosis
Time frame: 3 years
Percentage of hepatologists accepting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.
3 secondary outcomes
Trust in non-invasive methods
Time frame: 3 years
use of non-invasive methods
Time frame: 3 years
combining non-invasive methods
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
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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.
Mohamed Alboraie, M.Sc principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Fibrosis, run by Al-Azhar University at 1 site 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: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic fibrosis (time frame: 3 years). 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 11 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.