Hepatocellular CarcinomaNCT05738772
Diagnostic Accuracy of APAC, ASAP and GALAD Scores in Hepatocellular Carcinoma Among 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 common primary liver malignancy with most patients developing HCC due to chronic liver diseases. Unfortunately, HCC has a morality to incidence ratio that approaches 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- serum sample for ELIZA
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 90 adult patients with liver cirrhosis attending the outpatient clinic or inpatient 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.:
Who may be able to join
- A total of 90 adult patients with liver cirrhosis attending the outpatient clinic or inpatient 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
Who cannot join
- 1. patients aged <18 years old. 2. Presence of clinically suspected other causes of hepatocellular injury (any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Wilson's disease, fatty liver diseases with metabolic syndrome \& drug induced liver disease). 3. Receipt of any tumor specific therapy before blood samples collection. 4. Any patients who are on warfarin will be excluded as warfarin can elevate the DCP level in the absence of HCC. 5. Patients having malignancies other than HCC. 6. Presence of distant metastasis. 7. Presence of venous thromboembolism including portal vein thrombosis
Trial locations and contacts
1 site in 1 country.
Khairy H Morsy, professor contact
About this study
Hepatocellular carcinoma (HCC) is the most common primary liver malignancy with most patients developing HCC due to chronic liver diseases. Unfortunately, HCC has a morality to incidence ratio that approaches 1.
Among the etiological factors associated with HCC, hepatitis C virus (HCV) and Hepatitis B virus (HBV) infections are major risk factors. Despite HBV vaccination programs and effective direct antiviral agents (DAA) for treatment of HCV, the incidence of virus-related HCC remains high. HCV eradication by antiviral treatment reduces but does not eliminate HCC risk. Patients with HCV-related cirrhosis require HCC surveillance even after sustained virologic response (SVR) due to a persistent risk of HCC even years after SVR . In Egypt, HCC represents the fourth common cancer and is the most common cause of mortality-related and morbidity-related cancer. Egypt ranks the third and 15th most populous country in Africa and worldwide, respectively, and the Egyptian health authorities consider HCC as one of the most challenging health problems for the current decade. Both HCC screening and monitoring efforts have improved significantly since 2018 as a result of the national screening campaign .The early diagnosis of HCC is essential to initiate curative treatments to improve short term and long-term prognosis. Therefore, highly effective methods are needed to detect HCC at an earlier stage. American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) guidelines recommend the periodic use of ultrasound scanning (USS), with or without Alpha-fetoprotein (AFP) evaluation, for HCC surveillance. However, suboptimal performance of USS has been reported, with its sensitivity being compromised by the extent of liver cirrhosis, high body mass index (BMI), etiology of liver disease, expertise of the operator and quality of the equipment. Moreover, its sensitivity and specificity for early-stage HCC was found to be rather low . Serum biomarkers play an essential role in diagnosing HCC, as biomarkers are often more convenient, inexpensive, non-invasive, and reproducible . Alpha-fetoprotein (AFP) is a widely used biomarker for HCC diagnosis. The diagnostic accuracy of AFP is limited, however, due to its high false-negative rate to detect small or early stage tumors. As previous studies have demonstrated, the sensitivity of AFP among patients with HCC was 52% for tumors > 3cm and dropped to only 25% for tumors < 3cm. In addition, AFP may also be elevated in some benign liver diseases, such as chronic hepatitis and cirrhosis even in the absence of HCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- serum sample for ELIZA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum sample for ELIZADiagnostic test
Assay of AFP, AFP-L3, DCP and Soluble PDGFRβwill be done by enzyme-linked immunosorbent assay (ELISA).
| Study group | Role | What they receive |
|---|---|---|
| hcc group | The study group will include 45 patients with HCC on top of liver cirrhosis. All virus-related liver cirrhosis and all BCLC stages of HCC will be accepted. Verified presence of HCC, will be assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) or based on histological validation. In patients with presence of liver cirrhosis, non-invasive diagnosis of HCC is standard, when dynamic imaging shows typical diagnostic patterns as the combination of hypervascularity in late arterial phase and washout on portal venous and/or delayed phases Receives: Diagnostic Test: serum sample for ELIZA | |
| LC group | Will include 45 patients diagnosed with liver cirrhosis on top of HCV or HBV with an absence of focal lesions on ultrasound screening as a control group. Cirrhosis will be determined according to clinical, serological, and radiological findings Receives: Diagnostic Test: serum sample for ELIZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum level of AFP-L3.
Assay of AFP-L3 will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05
× age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
Measured: one year
serum level of DCP
Assay of DCP will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05
× age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
Measured: 1 year
Serum level of Soluble PDGFRβ
Assay of Soluble PDGFRβ will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05
× age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
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 posted22 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (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, Sara Mahmoud Mohammed Mohammed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738772
- Sponsor's protocol ID
- Soh-Med-23-02-15
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caviglia GP, Ribaldone DG, Abate ML, Ciancio A, Pellicano R, Smedile A, Saracco GM. Performance of protein induced by vitamin K absence or antagonist-II assessed by chemiluminescence enzyme immunoassay for hepatocellular carcinoma detection: a meta-analysis. Scand J Gastroenterol. 2018 Jun;53(6):734-740. doi: 10.1080/00365521.2018.1459824. Epub 2018 Apr 18.
PubMed 29667463Choi JY, Jung SW, Kim HY, Kim M, Kim Y, Kim DG, Oh EJ. Diagnostic value of AFP-L3 and PIVKA-II in hepatocellular carcinoma according to total-AFP. World J Gastroenterol. 2013 Jan 21;19(3):339-46. doi: 10.3748/wjg.v19.i3.339.
PubMed 23372355D'Ambrosio R, Colombo M. Should surveillance for liver cancer be modified in hepatitis C patients after treatment-related cirrhosis regression? Liver Int. 2016 Jun;36(6):783-90. doi: 10.1111/liv.13106. Epub 2016 Mar 24.
PubMed 26936383Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
PubMed 28130846
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of APAC, ASAP and GALAD Scores in Hepatocellular Carcinoma Among Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT05738772
- Acronym / sponsor ID
- Soh-Med-23-02-15
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 22 Feb 2023 (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 common primary liver malignancy with most patients developing HCC due to chronic liver diseases. Unfortunately, HCC has a morality to incidence ratio that approaches 1.
Among the etiological factors associated with HCC, hepatitis C virus (HCV) and Hepatitis B virus (HBV) infections are major risk factors. Despite HBV vaccination programs and effective direct antiviral agents (DAA) for treatment of HCV, the incidence of virus-related HCC remains high. HCV eradication by antiviral treatment reduces but does not eliminate HCC risk. Patients with HCV-related cirrhosis require HCC surveillance even after sustained virologic response (SVR) due to a persistent risk of HCC even years after SVR . In Egypt, HCC represents the fourth common cancer and is the most common cause of mortality-related and morbidity-related cancer. Egypt ranks the third and 15th most populous country in Africa and worldwide, respectively, and the Egyptian health authorities consider HCC as one of the most challenging health problems for the current decade. Both HCC screening and monitoring efforts have improved significantly since 2018 as a result of the national screening campaign .The early diagnosis of HCC is essential to initiate curative treatments to improve short term and long-term prognosis. Therefore, highly effective methods are needed to detect HCC at an earlier stage. American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) guidelines recommend the periodic use of ultrasound scanning (USS), with or without Alpha-fetoprotein (AFP) evaluation, for HCC surveillance. However, suboptimal performance of USS has been reported, with its sensitivity being compromised by the extent of liver cirrhosis, high body mass index (BMI), etiology of liver disease, expertise of the operator and quality of the equipment. Moreover, its sensitivity and specificity for early-stage HCC was found to be rather low . Serum biomarkers play an essential role in diagnosing HCC, as biomarkers are often more convenient, inexpensive, non-invasive, and reproducible . Alpha-fetoprotein (AFP) is a widely used biomarker for HCC diagnosis. The diagnostic accuracy of AFP is limited, however, due to its high false-negative rate to detect small or early stage tumors. As previous studies have demonstrated, the sensitivity of AFP among patients with HCC was 52% for tumors > 3cm and dropped to only 25% for tumors < 3cm. In addition, AFP may also be elevated in some benign liver diseases, such as chronic hepatitis and cirrhosis even in the absence of HCC.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hcc group | – | Diagnostic Test: serum sample for ELIZAThe study group will include 45 patients with HCC on top of liver cirrhosis. All virus-related liver cirrhosis and all BCLC stages of HCC will be accepted. Verified presence of HCC, will be assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) or based on histological validation. In patients with presence of liver cirrhosis, non-invasive diagnosis of HCC is standard, when dynamic imaging shows typical diagnostic patterns as the combination of hypervascularity in late arterial phase and washout on portal venous and/or delayed phases |
| LC group | – | Diagnostic Test: serum sample for ELIZAWill include 45 patients diagnosed with liver cirrhosis on top of HCV or HBV with an absence of focal lesions on ultrasound screening as a control group. Cirrhosis will be determined according to clinical, serological, and radiological findings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 90 adult patients with liver cirrhosis attending the outpatient clinic or inpatient 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.:
Key inclusion criteria (1 listed)
- A total of 90 adult patients with liver cirrhosis attending the outpatient clinic or inpatient 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
Key exclusion criteria (1 listed)
- 1. patients aged <18 years old. 2. Presence of clinically suspected other causes of hepatocellular injury (any history of alcoholism, autoimmune hepatitis, primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Wilson's disease, fatty liver diseases with metabolic syndrome \& drug induced liver disease). 3. Receipt of any tumor specific therapy before blood samples collection. 4. Any patients who are on warfarin will be excluded as warfarin can elevate the DCP level in the absence of HCC. 5. Patients having malignancies other than HCC. 6. Presence of distant metastasis. 7. Presence of venous thromboembolism including portal vein thrombosis
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 |
|---|---|---|
| serum sample for ELIZAAssay of AFP, AFP-L3, DCP and Soluble PDGFRβwill be done by enzyme-linked immunosorbent assay (ELISA). | Diagnostic test | LC group, hcc group |
Primary outcome
serum level of AFP-L3.
Time frame: one year
Assay of AFP-L3 will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05 × age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
serum level of DCP
Time frame: 1 year
Assay of DCP will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05 × age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
Serum level of Soluble PDGFRβ
Time frame: 1 year
Assay of Soluble PDGFRβ will be done by enzyme-linked immunosorbent assay (ELISA) then Diagnostic scoring tools were calculated using the following formulae:The GALAD score will be calculated using the following equation: GALAD score = - 10.08 + 0.09 × age + 1.67 × gender + 2.34 × Lg (AFP [ng/ml]) + 0.04 × AFP-L3%% + 1.33 × Lg (PIVKA-II [mAU/ml]), where gender = 0 for females and 1 for males. - The probability of HCC in a patient was calculated as follows: Pr (HCC)=exp (Z)/ (1 + exp (Z)) (z: GALAD)The ASAP score was calculated using the following equation: ASAP score = -7.58 + 0.05 × age - 0.58 × gender +0.42 × Ln (AFP [ng/ml]) + 1.11 × Ln (PIVIKA-II [mAU/ml]), where gender = 0 for males and 1 for femalesThe APAC score = (Age [years] x 0.20480) - (log10(sPDGFRβ [pg/mL]) x 1.98684) + (log10(AFP [ng/mL]) x 2.45657) - (Creatinine [mg/dL] x 2.46891) - 4.36493
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 29667463Caviglia GP, Ribaldone DG, Abate ML, Ciancio A, Pellicano R, Smedile A, Saracco GM. Performance of protein induced by vitamin K absence or antagonist-II assessed by chemiluminescence enzyme immunoassay for hepatocellular carcinoma detection: a meta-analysis. Scand J Gastroenterol. 2018 Jun;53(6):734-740. doi: 10.1080/00365521.2018.1459824. Epub 2018 Apr 18.
- Background: PubMed 23372355Choi JY, Jung SW, Kim HY, Kim M, Kim Y, Kim DG, Oh EJ. Diagnostic value of AFP-L3 and PIVKA-II in hepatocellular carcinoma according to total-AFP. World J Gastroenterol. 2013 Jan 21;19(3):339-46. doi: 10.3748/wjg.v19.i3.339.
- Background: PubMed 26936383D'Ambrosio R, Colombo M. Should surveillance for liver cancer be modified in hepatitis C patients after treatment-related cirrhosis regression? Liver Int. 2016 Jun;36(6):783-90. doi: 10.1111/liv.13106. Epub 2016 Mar 24.
- Background: PubMed 28130846Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Khairy H Morsy, 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 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 22 Feb 2023. 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 Sara M Mohammed, assistant lecturer (01028587557, sara_mohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum level of AFP-L3. (time frame: one year). The study lists 3 primary outcomes in all. 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 NCT05738772, 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 22 Feb 2023.