ALBI and PALBI Scores and HCC Prognosis

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT05720195

Collaborator

(none)

645

Enrollment

Location

Actual Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma (HCC) Prognosis	Diagnostic Test: ALBI

Study Design

Study Type:

Observational

Actual Enrollment :

645 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of Prognostic Accuracy of Albumin-Bilirubin and Platelet-Albumin-Bilirubin Grades in Hepatocellular Carcinoma Patients According to Different Treatment Modalities

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Overall survival among HCC patients as assessed by the albumin-bilirubin (ALBI) score [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 [2 years]
We will compare the ability of PALBI score to predict overall survival among HCC patients versus Child Pugh and MELD scores

Secondary Outcome Measures

Overall survival among HCC patients according to treatment modality as assessed by the albumin-bilirubin (ALBI) score [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)
Overall survival among HCC patients according to treatment modality as assessed by the platelet-albumin-bilirubin (PALBI) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt	82524

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Abudeif Abdelaal, MD, Principal investigator, Sohag University

ClinicalTrials.gov Identifier:

NCT05720195

Other Study ID Numbers:

Soh-Med-21-10-41

First Posted:

Feb 9, 2023

Last Update Posted:

Feb 9, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Feb 9, 2023