Taurine in HCCNCT04193761
TAURINE and HCC PATIENTS
A study testing taurine level in people with Taurine in HCC, run by Ain Shams University at 1 site in Egypt.
Trial summary
Serum taurine level beside (AFP and AFU) are of great value in early diagnosis in HCC Egyptian patients and may have a rule in identifying end-stage liver disease (ESLD) patients candidate for LDLT. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Taurine in HCC
- What is being tested?
- taurine level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Mar 2017to 25 Oct 2018
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic hepatitis
- Cirrhosis
- HCC patients
Who cannot join
- Patient refusal
- Bleeding tendency
- Tense ascites
- Inability to obtain a liver biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON BETWEEN SERUM TAURINE AND SPECIFIC TUMOR MARKERS FOR EARLY DETECTION AND DIAGNOSIS OF HCC IN EGYPTIAN PATIENTS
Serum taurine level beside (AFP and AFU) are of great value in early diagnosis in HCC Egyptian patients and may have a rule in identifying end-stage liver disease (ESLD) patients candidate for LDLT.
Read the detailed description
Taurine has been demonstrated to have a direct and indirect antioxidant effect and to display antineoplastic activity by preventing angiogenesis and enhancing tumor cell apoptosis. Also it was suggested that measurement of serum taurine level in hepatic patients beside fibroscan is of great value in the early diagnosis of any fibrotic and cancerous liver changes.Aim of the work was to correlate serum taurine level with the levels of the specific tumor markers (α- fetoprotein and α-L-fucosidase ) for early diagnosis of different stages of HCC in Egyptian patients.
This observational case-control study was conducted in the Tropical Medicine Department, Ahmed Maher Teaching Hospital. Eighty hepatic patients were assigned to three groups (Chronic hepatitis, Cirrhosis and HCC). Twenty healthy subjects were enrolled as a control group. Serum levels of AFP, AFU, and taurine beside complete biochemical analysis and liver biopsies from all selected patients were done. Patients who accepted to be a candidate for living donor liver transplant (LDLT) were referred to Ain Shams University Specialized Hospital (ASUSH) liver transplant unit.
- Conditions
- Taurine in HCC
- Being tested
- taurine level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taurine levelDiagnostic test
Taurine: determined by High-Performance Liquid Chromatography according to the pre-column extraction and derivatization methodology of McMahon et al. in the present work we use the Shimadzu, Japan HPLC model LC-10 AT.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Diagnostic Test: taurine level |
| Chronic hepatitis | Active comparator | Not described Receives: Diagnostic Test: taurine level |
| Cirrhosis | Active comparator | Not described Receives: Diagnostic Test: taurine level |
| Hepatocellular carcinoma | Active comparator | Not described Receives: Diagnostic Test: taurine level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taurine level among patients groups
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start17 Mar 2017
- Primary completion20 Apr 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taurine in HCCStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193761
- Sponsor's protocol ID
- HAM00077
- Status last verified
- Dec 2019
- First submitted
- 7 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON BETWEEN SERUM TAURINE AND SPECIFIC TUMOR MARKERS FOR EARLY DETECTION AND DIAGNOSIS OF HCC IN EGYPTIAN PATIENTS
- ClinicalTrials.gov ID
- NCT04193761
- Acronym / sponsor ID
- HAM00077
- Conditions
- Taurine in HCC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 10 Dec 2019 (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.
Serum taurine level beside (AFP and AFU) are of great value in early diagnosis in HCC Egyptian patients and may have a rule in identifying end-stage liver disease (ESLD) patients candidate for LDLT.
Detailed description
Taurine has been demonstrated to have a direct and indirect antioxidant effect and to display antineoplastic activity by preventing angiogenesis and enhancing tumor cell apoptosis. Also it was suggested that measurement of serum taurine level in hepatic patients beside fibroscan is of great value in the early diagnosis of any fibrotic and cancerous liver changes.Aim of the work was to correlate serum taurine level with the levels of the specific tumor markers (α- fetoprotein and α-L-fucosidase ) for early diagnosis of different stages of HCC in Egyptian patients.
This observational case-control study was conducted in the Tropical Medicine Department, Ahmed Maher Teaching Hospital. Eighty hepatic patients were assigned to three groups (Chronic hepatitis, Cirrhosis and HCC). Twenty healthy subjects were enrolled as a control group. Serum levels of AFP, AFU, and taurine beside complete biochemical analysis and liver biopsies from all selected patients were done. Patients who accepted to be a candidate for living donor liver transplant (LDLT) were referred to Ain Shams University Specialized Hospital (ASUSH) liver transplant unit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Diagnostic Test: taurine level |
| Chronic hepatitis | Active comparator | Diagnostic Test: taurine level |
| Cirrhosis | Active comparator | Diagnostic Test: taurine level |
| Hepatocellular carcinoma | Active comparator | Diagnostic Test: taurine level |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic hepatitis
- Cirrhosis
- HCC patients
Key exclusion criteria (4 listed)
- Patient refusal
- Bleeding tendency
- Tense ascites
- Inability to obtain a liver biopsy
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 |
|---|---|---|
| taurine levelTaurine: determined by High-Performance Liquid Chromatography according to the pre-column extraction and derivatization methodology of McMahon et al. in the present work we use the Shimadzu, Japan HPLC model LC-10 AT. | Diagnostic test | Chronic hepatitis, Cirrhosis, Control, Hepatocellular carcinoma |
Primary outcome
Taurine level among patients groups
Time frame: 8 months
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 Dec 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taurine level in people with Taurine in HCC, run by Ain Shams 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 3 inclusion and 4 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 Dec 2019. 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?
Taurine level among patients groups (time frame: 8 months). 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 10 Dec 2019.