Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
Study NCT ID:
NCT06629857
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-10-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Cross Sectional Study Evaluating the Mean Levels of Alpha Fetoprotein in Patients of Hepatocellular Carcinoma and Its Correlates in Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], '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'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D005234', 'term': 'Fatty Liver'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Alpha-Fetoprotein (AFP) Levels in HCC Patients', 'timeFrame': 'Baseline measurement at time of diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Correlation Between AFP Levels and Tumor Size', 'timeFrame': 'At baseline (upon diagnosis).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma (HCC)', 'Alpha-fetoprotein (AFP) levels', 'Liver cancer biomarkers', 'Tumor size and AFP correlation', 'Hepatitis B and C in liver cancer', 'Non-alcoholic steatohepatitis (NASH)', 'AFP as a diagnostic tool', 'Liver tumor progression markers'], 'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the levels of alpha-fetoprotein (AFP), a protein often elevated in liver cancer, in patients with hepatocellular carcinoma (HCC). The goal is to determine whether AFP levels vary based on the size of the liver tumor or other health conditions like hepatitis B, hepatitis C, and obesity. By analyzing data from 94 patients, the study seeks to identify factors that influence AFP levels, which may help in understanding liver cancer progression and improving diagnosis and treatment approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '27 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of a total of 94 adult patients diagnosed with hepatocellular carcinoma (HCC) who are receiving care at Dar ul Sehat Hospital, Karachi, Pakistan. Participants will be recruited from outpatient, emergency, and inpatient departments. Eligible individuals will be aged between 27 to 80 years and must have been diagnosed with HCC within the last three months, confirmed by relevant investigations. The study aims to reflect a diverse population that includes various tumor sizes and underlying liver disease etiologies, such as hepatitis B, hepatitis C, non-alcoholic steatohepatitis, and cirrhosis. Patients will be excluded if they have elevated alpha-fetoprotein levels due to tumors other than HCC or have secondary liver metastases from other primary sites. This approach ensures that the findings are specific to HCC and its correlates, aiding in the assessment of AFP levels in this population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 27 to 80 years.\n* Diagnosed with hepatocellular carcinoma (HCC) within the last three months.\n* Diagnosis confirmed by relevant investigations (e.g., imaging, liver biopsy).\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Elevated alpha-fetoprotein levels due to tumors other than HCC.\n* Presence of secondary liver metastases from other primary sites.\n* Any significant comorbid conditions that could interfere with study assessments.\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06629857', 'briefTitle': 'A Cross Sectional Study Evaluating the Mean Levels of Alpha Fetoprotein in Patients of Hepatocellular Carcinoma and Its Correlates in Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Darul Sehat Hospital'}, 'officialTitle': 'Clinical Correlation of Alpha-Fetoprotein in Hepatocellular Carcinoma: a Cross-Sectional Study from Southeast Asia', 'orgStudyIdInfo': {'id': 'M-000037/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: HCC Patients with Elevated AFP Levels Description: This group includes patients diagnosed'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Darul Sehat Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Darul Sehat Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Maryam Abbasi', 'investigatorAffiliation': 'Jinnah Sindh Medical University'}}}}