Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT05720195
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2023-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALBI and PALBI Scores and HCC Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 645}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival among HCC patients as assessed by the albumin-bilirubin (ALBI) score', 'timeFrame': '2 years', 'description': 'We will compare the ability of ALBI score to predict overall survival among HCC patients versus Child Pugh and MELD scores'}, {'measure': 'Overall survival among HCC patients as assessed by the platelet-albumin-bilirubin (PALBI) score', 'timeFrame': '2 years', 'description': 'We will compare the ability of PALBI score to predict overall survival among HCC patients versus Child Pugh and MELD scores'}], 'secondaryOutcomes': [{'measure': 'Overall survival among HCC patients according to treatment modality as assessed by the albumin-bilirubin (ALBI) score', 'timeFrame': '2 years', 'description': '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)'}, {'measure': 'Overall survival among HCC patients according to treatment modality as assessed by the platelet-albumin-bilirubin (PALBI)', 'timeFrame': '2 years', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma (HCC) Prognosis']}, 'descriptionModule': {'briefSummary': 'To compare the predictive ability of ALBI and PALBI grades with CTP and MELD scores.\n\nTo investigate the efficacy of ALBI and PALBI grades for predicting the prognosis of HCC and overall survival among different modalities of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• 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.\n\nExclusion Criteria:\n\n* Patients below 18 years old.\n* Patients with pre-existing other malignancies.\n* Patients with pre-existing gall bladder stones, benign strictures, or other biliary diseases.\n* Patients with pre-existing haematologic disorders.\n* Patients with proteinuria.\n* Missed follow-up.'}, 'identificationModule': {'nctId': 'NCT05720195', 'briefTitle': 'ALBI and PALBI Scores and HCC Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Assessment of Prognostic Accuracy of Albumin-Bilirubin and Platelet-Albumin-Bilirubin Grades in Hepatocellular Carcinoma Patients According to Different Treatment Modalities', 'orgStudyIdInfo': {'id': 'Soh-Med-21-10-41'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ALBI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PALBI'], 'description': 'Albumin-Bilirubin and Platelet-Albumin-Bilirubin Grades for prognosis of HCC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ahmed Abudeif Abdelaal, MD', 'investigatorAffiliation': 'Sohag University'}}}}