Hepatocellular Carcinoma (HCC) PrognosisNCT05720195
ALBI and PALBI Scores and HCC Prognosis
An observational study of Hepatocellular Carcinoma (HCC) Prognosis, run by Sohag University at 1 site in Egypt.
Trial summary
To compare the predictive ability of ALBI and PALBI grades with CTP and MELD scores. To investigate the efficacy of ALBI and PALBI grades for predicting the prognosis of HCC and overall survival among different modalities of treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC) Prognosis
- What is being tested?
- ALBI
- How many people
- 645 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Dec 2022
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include all patients diagnosed with HCC both males and females equal to or above 18 years old, attending the outpatient clinic or admitted at the inpatient section of Tropical Medicine and Gastroenterology Department, Sohag University Hospital
Who may be able to join
- The diagnosis of HCC will be based on the presence of an arterial hypervascular focal lesion > 2 cm with rapid wash-out with a single imaging modality (triphasic computed tomography (CT), or dynamic magnetic resonance imaging (MRI)) or two imaging modalities demonstrating the before mentioned feature for lesions < 2 cm with or without elevated serum alpha-fetoprotein (AFP) levels.
Who cannot join
- Patients below 18 years old.
- Patients with pre-existing other malignancies.
- Patients with pre-existing gall bladder stones, benign strictures, or other biliary diseases.
- Patients with pre-existing haematologic disorders.
- Patients with proteinuria.
- Missed follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Prognostic Accuracy of Albumin-Bilirubin and Platelet-Albumin-Bilirubin Grades in Hepatocellular Carcinoma Patients According to Different Treatment Modalities
To compare the predictive ability of ALBI and PALBI grades with CTP and MELD scores.
To investigate the efficacy of ALBI and PALBI grades for predicting the prognosis of HCC and overall survival among different modalities of treatment.
- Conditions
- Hepatocellular Carcinoma (HCC) Prognosis
- Being tested
- ALBI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALBIDiagnostic test
Also called PALBI
Albumin-Bilirubin and Platelet-Albumin-Bilirubin Grades for prognosis of HCC
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival among HCC patients as assessed by the albumin-bilirubin (ALBI) score
We will compare the ability of ALBI score to predict overall survival among HCC patients versus Child Pugh and MELD scores
Measured: 2 years
Overall survival among HCC patients as assessed by the platelet-albumin-bilirubin (PALBI) score
We will compare the ability of PALBI score to predict overall survival among HCC patients versus Child Pugh and MELD scores
Measured: 2 years
Secondary outcomes (2)
Overall survival among HCC patients according to treatment modality as assessed by the albumin-bilirubin (ALBI) score
We will compare the ability of ALBI score to predict overall survival among HCC patients stratified according to treatment modality (Surgical resection, local ablation, trans-arterial chemoembolization, sorafenib and best supportive care)
Measured: 2 years
Overall survival among HCC patients according to treatment modality as assessed by the platelet-albumin-bilirubin (PALBI)
We will compare the ability of PALBI score to predict overall survival among HCC patients stratified according to treatment modality (Surgical resection, local ablation, trans-arterial chemoembolization, sorafenib and best supportive care)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC) PrognosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abudeif Abdelaal, MD, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720195
- Sponsor's protocol ID
- Soh-Med-21-10-41
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- 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 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Prognostic Accuracy of Albumin-Bilirubin and Platelet-Albumin-Bilirubin Grades in Hepatocellular Carcinoma Patients According to Different Treatment Modalities
- ClinicalTrials.gov ID
- NCT05720195
- Acronym / sponsor ID
- Soh-Med-21-10-41
- Conditions
- Hepatocellular Carcinoma (HCC) Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 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.
To compare the predictive ability of ALBI and PALBI grades with CTP and MELD scores.
To investigate the efficacy of ALBI and PALBI grades for predicting the prognosis of HCC and overall survival among different modalities of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include all patients diagnosed with HCC both males and females equal to or above 18 years old, attending the outpatient clinic or admitted at the inpatient section of Tropical Medicine and Gastroenterology Department, Sohag University Hospital
Key inclusion criteria (1 listed)
- The diagnosis of HCC will be based on the presence of an arterial hypervascular focal lesion > 2 cm with rapid wash-out with a single imaging modality (triphasic computed tomography (CT), or dynamic magnetic resonance imaging (MRI)) or two imaging modalities demonstrating the before mentioned feature for lesions < 2 cm with or without elevated serum alpha-fetoprotein (AFP) levels.
Key exclusion criteria (6 listed)
- Patients below 18 years old.
- Patients with pre-existing other malignancies.
- Patients with pre-existing gall bladder stones, benign strictures, or other biliary diseases.
- Patients with pre-existing haematologic disorders.
- Patients with proteinuria.
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 |
|---|---|---|
| ALBIAlso: PALBIAlbumin-Bilirubin and Platelet-Albumin-Bilirubin Grades for prognosis of HCC | Diagnostic test | – |
Primary outcome
Overall survival among HCC patients as assessed by the albumin-bilirubin (ALBI) score
Time frame: 2 years
We will compare the ability of ALBI score to predict overall survival among HCC patients versus Child Pugh and MELD scores
Overall survival among HCC patients as assessed by the platelet-albumin-bilirubin (PALBI) score
Time frame: 2 years
We will compare the ability of PALBI score to predict overall survival among HCC patients versus Child Pugh and MELD scores
2 secondary outcomes
Overall survival among HCC patients according to treatment modality as assessed by the albumin-bilirubin (ALBI) score
Time frame: 2 years
Overall survival among HCC patients according to treatment modality as assessed by the platelet-albumin-bilirubin (PALBI)
Time frame: 2 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 9 Feb 2023.
- 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.
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?
An observational study of Hepatocellular Carcinoma (HCC) Prognosis, 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 6 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 9 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?
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?
Overall survival among HCC patients as assessed by the albumin-bilirubin (ALBI) score (time frame: 2 years). The study lists 2 primary outcomes in all. 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 9 Feb 2023.