Liver DiseasesELLNCT04465747
Egyptian Liver Library: Rebuilding the Pyramid of Liver Disease Evidence in Egypt
An observational study of Liver Diseases, run by Al-Azhar University at 1 site in Egypt.
Trial summary
A lot of publications about liver disease are available worldwide. Egypt is one of the countries having a large number of publications in hepatology. There are defects in reviewing this evidence and making use of it. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Publications
- How many people
- 5,068 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Jan 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Published articles about liver disease up to January 2016
Who may be able to join
- Published articles about liver disease up to January 2016
Who cannot join
- Anything else
Trial locations and contacts
1 site in 1 country.
About this study
A lot of publications about liver disease are available worldwide. Egypt is one of the countries having a large number of publications in hepatology. There are defects in reviewing this evidence and making use of it. Addressing the areas of weakness in liver research in Egypt is challenging to researchers and clinicians. Creating a library for liver disease evidence in Egypt can solve this problem and lead future research in hepatology in Egypt.
Read the detailed description
Egypt is considered one of the countries with large liver disease burden in the world being endemic with bilharziasis and hepatitis C for decades. Limitations in health care resource further augment the magnitude of the problem allowing the development of disease specific complications in absence of effective treatments over the past. With discovery of anti-schistosomal therapy and implementation of the national program for eliminating bilharziasis; bilharzial liver disease incidence regressed markedly. However; complications of bilharzial liver disease are still present. The situation has been repeated with hepatitis C which is still a major health problem in Egypt regardless of the availability of highly effective interferon free antiviral regimens. This is mainly due to the large number of infected patients (estimated to be more than 6 million) [1], re-infection and presence of complications that needs further management. The need for addressing these major health problems in Egypt provoked a lot of research in the field of hepatology. Egyptian and non-Egyptian researchers have published a lot of scientific reports about liver diseases in Egypt. Since the ancient age of the pharaohs there were written evidence about liver disease in Egypt. It was reported in the Ebres Papyrus (around 2600 BC) that hardness of the liver occurs secondary to excess alcohol ingestion [2]. This was one of the oldest documented detailed medical literatures in the history of mankind. In the recent age there were a lot reports from Egypt about bilharziasis and other parasitic infestations as the one published by Cobbold in 1982 about injurious parasites in Egypt [3]. Further enormous amount of publications has been released afterwards. Reviewing this evidence and creating an indexed data base for it could be of value for the national and international hepatology platforms. I aim with other colleagues at reviewing all published evidence in the field of hepatology from Egypt up to January 2016 and classifying it by different key words to build a data base of liver disease evidence in Egypt. This data base will be continuously updated by published data after January 1st 2016 and will be the reference for researchers from Egypt and rest of the world. The data base will invite all authors from Egypt to provide their raw data of published articles to be available for further analyses by other researchers. Moreover the data base work team will start a series of systematic reviews and meta analyses for the available relevant data aiming at addressing the areas of strength and areas of weakness in liver disease research in Egypt making further recommendations to the research authorities about what is missing and how it is better to be addressed in their future research calls. This pilot research work can be reproduced elsewhere by other researchers in their own countries making use of their published data and advising their local research authorities to fill up the gaps in liver research in their own countries. Hopefully in the near future we will have these groups working together in a network driving liver research globally.
- Conditions
- Liver Diseases
- Being tested
- Publications
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PublicationsOther
Reviewing published evidence
What is being measured
The primary outcome is the main question the study is designed to answer.
Review of all published articles about liver disease in Egypt till April 2017
Indexing articles according to types of liver disease
Measured: 1 year
Secondary outcomes (1)
Identifying missing diseases in hepatology research in Egypt
Identifying missing diseases in hepatology research in Egypt
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study startJan 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,068 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.D., MRCP, Principal investigator, Al-Azhay University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465747
- Sponsor's protocol ID
- MB-2
- Acronym
- ELL
- Status last verified
- Jul 2020
- First submitted
- 30 Jan 2016
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bruggmann, P., Berg, T., Øvrehus, A. L. H., Moreno, C., Brandão Mello, C. E., Roudot-Thoraval, F., Marinho, R. T., Sherman, M., Ryder, S. D., Sperl, J., Akarca, U., Balık, İ., Bihl, F., Bilodeau, M., Blasco, A. J., Buti, M., Calinas, F., Calleja, J. L., Cheinquer, H., Christensen, P. B., Clausen, M., Coelho, H. S. M., Cornberg, M., Cramp, M. E., Dore, G. J., Doss, W., Duberg, A. S., El-Sayed, M. H., Ergör, G., Esmat, G., Estes, C., Falconer, K., Félix, J., Ferraz, M. L. G., Ferreira, P. R., Frankova, S., García-Samaniego, J., Gerstoft, J., Giria, J. A., Gonçales, F. L., Gower, E., Gschwantler, M., Guimarães Pessôa, M., Hézode, C., Hofer, H., Husa, P., Idilman, R., Kåberg, M., Kaita, K. D. E., Kautz, A., Kaymakoglu, S., Krajden, M., Krarup, H., Laleman, W., Lavanchy, D., Lázaro, P., Marotta, P., Mauss, S., Mendes Correa, M. C., Müllhaupt, B., Myers, R. P., Negro, F., Nemecek, V., Örmeci, N., Parkes, J., Peltekian, K. M., Ramji, A., Razavi, H., Reis, N., Roberts, S. K., Rosenberg, W. M., Sarmento-Castro, R., Sarrazin, C., Semela, D., Shiha, G. E., Sievert, W., Stärkel, P., Stauber, R. E., Thompson, A. J., Urbanek, P., van Thiel, I., Van Vlierberghe, H., Vandijck, D., Vogel, W., Waked, I., Wedemeyer, H., Weis, N., Wiegand, J., Yosry, A., Zekry, A., Van Damme, P., Aleman, S. and Hindman, S. J. (2014), Historical epidemiology of hepatitis C virus (HCV) in selected countries. Journal of Viral Hepatitis, 21: 5-33. doi: 10.1111/jvh.12247
Starr SP, Raines D. Cirrhosis: diagnosis, management, and prevention. Am Fam Physician. 2011 Dec 15;84(12):1353-9.
PubMed 22230269Cobbold TS. Remarks on Injurious Parasites of Egypt in Relation to Water-Drinking. Br Med J. 1882 Sep 16;2(1133):503-4. doi: 10.1136/bmj.2.1133.503. No abstract available.
PubMed 20750313
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egyptian Liver Library: Rebuilding the Pyramid of Liver Disease Evidence in Egypt
- ClinicalTrials.gov ID
- NCT04465747
- Acronym / sponsor ID
- ELL / MB-2
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,068 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 10 Jul 2020 (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.
A lot of publications about liver disease are available worldwide. Egypt is one of the countries having a large number of publications in hepatology. There are defects in reviewing this evidence and making use of it. Addressing the areas of weakness in liver research in Egypt is challenging to researchers and clinicians. Creating a library for liver disease evidence in Egypt can solve this problem and lead future research in hepatology in Egypt.
Detailed description
Egypt is considered one of the countries with large liver disease burden in the world being endemic with bilharziasis and hepatitis C for decades. Limitations in health care resource further augment the magnitude of the problem allowing the development of disease specific complications in absence of effective treatments over the past. With discovery of anti-schistosomal therapy and implementation of the national program for eliminating bilharziasis; bilharzial liver disease incidence regressed markedly. However; complications of bilharzial liver disease are still present. The situation has been repeated with hepatitis C which is still a major health problem in Egypt regardless of the availability of highly effective interferon free antiviral regimens. This is mainly due to the large number of infected patients (estimated to be more than 6 million) [1], re-infection and presence of complications that needs further management. The need for addressing these major health problems in Egypt provoked a lot of research in the field of hepatology. Egyptian and non-Egyptian researchers have published a lot of scientific reports about liver diseases in Egypt. Since the ancient age of the pharaohs there were written evidence about liver disease in Egypt. It was reported in the Ebres Papyrus (around 2600 BC) that hardness of the liver occurs secondary to excess alcohol ingestion [2]. This was one of the oldest documented detailed medical literatures in the history of mankind. In the recent age there were a lot reports from Egypt about bilharziasis and other parasitic infestations as the one published by Cobbold in 1982 about injurious parasites in Egypt [3]. Further enormous amount of publications has been released afterwards. Reviewing this evidence and creating an indexed data base for it could be of value for the national and international hepatology platforms. I aim with other colleagues at reviewing all published evidence in the field of hepatology from Egypt up to January 2016 and classifying it by different key words to build a data base of liver disease evidence in Egypt. This data base will be continuously updated by published data after January 1st 2016 and will be the reference for researchers from Egypt and rest of the world. The data base will invite all authors from Egypt to provide their raw data of published articles to be available for further analyses by other researchers. Moreover the data base work team will start a series of systematic reviews and meta analyses for the available relevant data aiming at addressing the areas of strength and areas of weakness in liver disease research in Egypt making further recommendations to the research authorities about what is missing and how it is better to be addressed in their future research calls. This pilot research work can be reproduced elsewhere by other researchers in their own countries making use of their published data and advising their local research authorities to fill up the gaps in liver research in their own countries. Hopefully in the near future we will have these groups working together in a network driving liver research globally.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Published articles about liver disease up to January 2016
Key inclusion criteria (1 listed)
- Published articles about liver disease up to January 2016
Key exclusion criteria (1 listed)
- Anything else
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 |
|---|---|---|
| PublicationsReviewing published evidence | Other | – |
Primary outcome
Review of all published articles about liver disease in Egypt till April 2017
Time frame: 1 year
Indexing articles according to types of liver disease
1 secondary outcome
Identifying missing diseases in hepatology research in Egypt
Time frame: 1 year
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 10 Jul 2020.
- BackgroundBruggmann, P., Berg, T., Øvrehus, A. L. H., Moreno, C., Brandão Mello, C. E., Roudot-Thoraval, F., Marinho, R. T., Sherman, M., Ryder, S. D., Sperl, J., Akarca, U., Balık, İ., Bihl, F., Bilodeau, M., Blasco, A. J., Buti, M., Calinas, F., Calleja, J. L., Cheinquer, H., Christensen, P. B., Clausen, M., Coelho, H. S. M., Cornberg, M., Cramp, M. E., Dore, G. J., Doss, W., Duberg, A. S., El-Sayed, M. H., Ergör, G., Esmat, G., Estes, C., Falconer, K., Félix, J., Ferraz, M. L. G., Ferreira, P. R., Frankova, S., García-Samaniego, J., Gerstoft, J., Giria, J. A., Gonçales, F. L., Gower, E., Gschwantler, M., Guimarães Pessôa, M., Hézode, C., Hofer, H., Husa, P., Idilman, R., Kåberg, M., Kaita, K. D. E., Kautz, A., Kaymakoglu, S., Krajden, M., Krarup, H., Laleman, W., Lavanchy, D., Lázaro, P., Marotta, P., Mauss, S., Mendes Correa, M. C., Müllhaupt, B., Myers, R. P., Negro, F., Nemecek, V., Örmeci, N., Parkes, J., Peltekian, K. M., Ramji, A., Razavi, H., Reis, N., Roberts, S. K., Rosenberg, W. M., Sarmento-Castro, R., Sarrazin, C., Semela, D., Shiha, G. E., Sievert, W., Stärkel, P., Stauber, R. E., Thompson, A. J., Urbanek, P., van Thiel, I., Van Vlierberghe, H., Vandijck, D., Vogel, W., Waked, I., Wedemeyer, H., Weis, N., Wiegand, J., Yosry, A., Zekry, A., Van Damme, P., Aleman, S. and Hindman, S. J. (2014), Historical epidemiology of hepatitis C virus (HCV) in selected countries. Journal of Viral Hepatitis, 21: 5-33. doi: 10.1111/jvh.12247
- Results publication: PubMed 22230269Starr SP, Raines D. Cirrhosis: diagnosis, management, and prevention. Am Fam Physician. 2011 Dec 15;84(12):1353-9.
- Results publication: PubMed 20750313Cobbold TS. Remarks on Injurious Parasites of Egypt in Relation to Water-Drinking. Br Med J. 1882 Sep 16;2(1133):503-4. doi: 10.1136/bmj.2.1133.503. No abstract available.
- 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.
Mohamed Alboraie, M.D., MRCP principal investigator
Al-Azhay University, Cairo, Egypt
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 Liver Diseases, 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 10 Jul 2020. 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?
Review of all published articles about liver disease in Egypt till April 2017 (time frame: 1 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 NCT04465747, which also lists 3 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 10 Jul 2020.