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Completed

NCT Number: NCT05720195

ALBI and PALBI Scores and HCC Prognosis

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Prognosis Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University

Sohag, 82524, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALBI

Diagnostic Test

Albumin-Bilirubin and Platelet-Albumin-Bilirubin Grades for prognosis of HCC

Other names: PALBI

Primary outcomes

  1. 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. 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

Secondary outcomes

  1. 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. 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)

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2023
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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