Hepatocellular CarcinomaNCT06328283
The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of Hepatocellular Carcinoma in Cirrhotic Patients
An observational study of Hepatocellular Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- measure of Glutamine synthetase and BCLFAF1
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Mar 2026
- 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: - A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups: Group I: The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion Group II: The study group will include 45 patient with HCC on top of liver cirrhosis .
Who may be able to join
- A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups:
- Group I:
- The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion as control group. Cirrhosis will be determined according to clinical , sereological ,radiological findings.
- Group II:
- The study group will include 45 patient with HCC on top of liver cirrhosis .All causes of liver cirrhosis will be accepted .HCC will be assessed by triphasic CT or MRI or histological validation .In these group we will take patients with liver cirrhosis with early hepatocellular carcinoma that defined as tumors smaller than 3cm and three or fewer in number at stage A according to BCLC staging also sometimes it includes solitary tumors up to 5 cm in size as defined in the Milan criteria. Both very early and early stage tumors are relatively small but both are hyper vascular in arterial phase.
Who cannot join
- Non cirrhotic patients.
- Patients with distant metastasis.
- Patients aged below18 years.
- Patients with other malignancy rather than HCC.
- Patients with late stage of HCC.
Trial locations and contacts
1 site in 1 country.
mahmoud s el eslam, professor contact
About this study
Official title: The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of GLutamine Synthetase and BCLAF1 in Diagnosis of Hepatocellular in Cirrhotic Patients
Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.
HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- measure of Glutamine synthetase and BCLFAF1
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure of Glutamine synthetase and BCLFAF1Other
compare Glutamine synthetase and BCLFAF1 in cases and controls
| Study group | Role | What they receive |
|---|---|---|
| cases group | cirrhotic patients with early hepatocellular carcinoma Receives: Other: measure of Glutamine synthetase and BCLFAF1 | |
| control group | cirrhotic patients with no hepatocellular carcinoma Receives: Other: measure of Glutamine synthetase and BCLFAF1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
glutamine synthetase
to detect early HCC IN CIRRHOTIC
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 posted25 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (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 Sohag 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Safwat Abdelrahman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328283
- Sponsor's protocol ID
- Soh-Med-24-02-01MD
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mir IH, Guha S, Behera J, Thirunavukkarasu C. Targeting molecular signal transduction pathways in hepatocellular carcinoma and its implications for cancer therapy. Cell Biol Int. 2021 Nov;45(11):2161-2177. doi: 10.1002/cbin.11670. Epub 2021 Aug 1.
PubMed 34270844Singh G, Yoshida EM, Rathi S, Marquez V, Kim P, Erb SR, Salh BS. Biomarkers for hepatocellular cancer. World J Hepatol. 2020 Sep 27;12(9):558-573. doi: 10.4254/wjh.v12.i9.558.
PubMed 33033565Terentiev AA, Moldogazieva NT. Alpha-fetoprotein: a renaissance. Tumour Biol. 2013 Aug;34(4):2075-91. doi: 10.1007/s13277-013-0904-y. Epub 2013 Jun 14.
PubMed 23765762Wasfy RE, Shams Eldeen AA. Roles of Combined Glypican-3 and Glutamine Synthetase in Differential Diagnosis of Hepatocellular Lesions. Asian Pac J Cancer Prev. 2015;16(11):4769-75. doi: 10.7314/apjcp.2015.16.11.4769.
PubMed 26107238
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Efficacy of Glutamine Synthetaseand BCLAF1in Early Diagosis of GLutamine Synthetase and BCLAF1 in Diagnosis of Hepatocellular in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT06328283
- Acronym / sponsor ID
- Soh-Med-24-02-01MD
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 25 Mar 2024 (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.
Hepatocellular carcinoma (HCC) is the most prominent kind of liver cancer, accounting for 85% of primary liver malignancies. It is a very aggressive tumor, having a terrible prognosis and poor survival rate HCC is ranked as the sixth most common type of cancer and the third leading cause of cancer-related mortalities world wide.
HCC incidences arise in complications associated with chronic liver disease like cirrhosis, endemic hepatitis B virus (HBV)/hepatitis C virus (HCV) infections, non alcoholic fatty liver disease (NAFLD), and alcohol-related liver disease (Torre, 2015).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Other: measure of Glutamine synthetase and BCLFAF1cirrhotic patients with early hepatocellular carcinoma |
| control group | – | Other: measure of Glutamine synthetase and BCLFAF1cirrhotic patients with no hepatocellular carcinoma |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- - A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups: Group I: The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion Group II: The study group will include 45 patient with HCC on top of liver cirrhosis .
Key inclusion criteria (5 listed)
- A total 90 adult patients with liver cirrhosis attending the outpatient clinic or in patient section of the department of tropical medicine and gastroenterology at Sohag University Hospital will be included in the study. Patients will be divided into two groups:
- The study group will include 45 patients diagnosed with liver cirrhosis with absence of hepatic focal lesion as control group. Cirrhosis will be determined according to clinical , sereological ,radiological findings.
- The study group will include 45 patient with HCC on top of liver cirrhosis .All causes of liver cirrhosis will be accepted .HCC will be assessed by triphasic CT or MRI or histological validation .In these group we will take patients with liver cirrhosis with early hepatocellular carcinoma that defined as tumors smaller than 3cm and three or fewer in number at stage A according to BCLC staging also sometimes it includes solitary tumors up to 5 cm in size as defined in the Milan criteria. Both very early and early stage tumors are relatively small but both are hyper vascular in arterial phase.
Key exclusion criteria (5 listed)
- Non cirrhotic patients.
- Patients with distant metastasis.
- Patients aged below18 years.
- Patients with other malignancy rather than HCC.
- Patients with late stage of HCC.
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 |
|---|---|---|
| measure of Glutamine synthetase and BCLFAF1compare Glutamine synthetase and BCLFAF1 in cases and controls | Other | cases group, control group |
Primary outcome
glutamine synthetase
Time frame: 1 year
to detect early HCC IN CIRRHOTIC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 34270844Mir IH, Guha S, Behera J, Thirunavukkarasu C. Targeting molecular signal transduction pathways in hepatocellular carcinoma and its implications for cancer therapy. Cell Biol Int. 2021 Nov;45(11):2161-2177. doi: 10.1002/cbin.11670. Epub 2021 Aug 1.
- Background: PubMed 33033565Singh G, Yoshida EM, Rathi S, Marquez V, Kim P, Erb SR, Salh BS. Biomarkers for hepatocellular cancer. World J Hepatol. 2020 Sep 27;12(9):558-573. doi: 10.4254/wjh.v12.i9.558.
- Background: PubMed 23765762Terentiev AA, Moldogazieva NT. Alpha-fetoprotein: a renaissance. Tumour Biol. 2013 Aug;34(4):2075-91. doi: 10.1007/s13277-013-0904-y. Epub 2013 Jun 14.
- Background: PubMed 26107238Wasfy RE, Shams Eldeen AA. Roles of Combined Glypican-3 and Glutamine Synthetase in Differential Diagnosis of Hepatocellular Lesions. Asian Pac J Cancer Prev. 2015;16(11):4769-75. doi: 10.7314/apjcp.2015.16.11.4769.
- Individual participant dataSharing planned: Undecided
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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.
mahmoud s el eslam, professor contact
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 Hepatocellular Carcinoma, run by Sohag 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 5 inclusion and 5 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 25 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa s ABDELRHMAN, assistant lecutrer (01000496350, esraa.ahmed1@med.sohag.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glutamine synthetase (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 NCT06328283, 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 25 Mar 2024.