ALBI and PALBI Scores and HCC Prognosis

January 30, 2023 updated by: Ahmed Abudeif Abdelaal, MD, Sohag University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

645

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years
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 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival among HCC patients according to treatment modality 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 stratified according to treatment modality (Surgical resection, local ablation, trans-arterial chemoembolization, sorafenib and best supportive care)
2 years
Overall survival among HCC patients according to treatment modality as assessed by the platelet-albumin-bilirubin (PALBI)
Time Frame: 2 years
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)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-10-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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