Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 2:27 PM
Study NCT ID:
NCT05846035
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-18', 'releaseDate': '2025-07-01'}], 'estimatedResultsFirstSubmitDate': '2025-07-01'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prevalence of Paraneoplastic Syndrome in cirrhotic Patients with HCC.', 'timeFrame': '12 months', 'description': 'To investigate the prevalence of PNS (hypoglycemia, hypercholesterolemia, hypercalcemia, erythrocytosis, and thrombocytosis) and clinical characteristics in cirrhotic Patients with HCC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma Patients']}, 'referencesModule': {'references': [{'pmid': '35412368', 'type': 'BACKGROUND', 'citation': 'Borde T, Nezami N, Laage Gaupp F, Savic LJ, Taddei T, Jaffe A, Strazzabosco M, Lin M, Duran R, Georgiades C, Hong K, Chapiro J. Optimization of the BCLC Staging System for Locoregional Therapy for Hepatocellular Carcinoma by Using Quantitative Tumor Burden Imaging Biomarkers at MRI. Radiology. 2022 Jul;304(1):228-237. doi: 10.1148/radiol.212426. Epub 2022 Apr 12.'}, {'pmid': '24480222', 'type': 'BACKGROUND', 'citation': 'Qu Q, Wang S, Chen S, Zhou L, Rui JA. Prognostic role and significance of paraneoplastic syndromes in hepatocellular carcinoma. Am Surg. 2014 Feb;80(2):191-6.'}, {'pmid': '34422400', 'type': 'BACKGROUND', 'citation': 'Samant H, Amiri HS, Zibari GB. Addressing the worldwide hepatocellular carcinoma: epidemiology, prevention and management. J Gastrointest Oncol. 2021 Jul;12(Suppl 2):S361-S373. doi: 10.21037/jgo.2020.02.08.'}]}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world with rising incidence. Globally, there has been substantial variation in prevalence of risk factors for HCC over years, like control of viral hepatitis in developing countries but growing epidemic of fatty liver disease in developed world. Changing epidemiology of HCC is related to trends in these risk factors, Paraneoplastic syndromes (PNS) are defined as systemic, metabolic, or other distant consequences of malignancy resulting, either directly or indirectly, from production by the neoplasm of substances that gain access to the blood stream, thereby exerting their effects on distant organs or tissues There is four major HCC-associated paraneoplastic syndromes among Cirrhotic patients,i.e.hypercholesterolemia,hypoglycemia,hypercalcemia,and erythrocytosis .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Cirrhotic Patients with HCC.\n* HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Cirrhotic Patients with HCC.\n* HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.\n\nExclusion Criteria:\n\n* \\- Patient known to have primary parathyroid disease, patients with bone metastasis or excessive use of antacids.\n* Patients with secondary polycythemia (as chronic hypoxia) and patients with polycythemia rubra vera.\n* Patients with acute infections or GIT bleeding.\n* Patients with preexisting dyslipidemia.\n* Patients with significant cholestasis.'}, 'identificationModule': {'nctId': 'NCT05846035', 'briefTitle': 'Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients', 'orgStudyIdInfo': {'id': 'Soh-Med-23-04-12MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Triphasic C.T abdomen and pelvis', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['alpha feto protein'], 'description': 'for cirrhotic patients to ensure hepatocellular carcinoma'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag University hospitals', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Hala M Abdelhafeez, Resident', 'role': 'CONTACT', 'email': 'halamaher@med.sohag.edu.eg', 'phone': '01027319657'}, {'name': 'Amr M Zaghloul, Assistant professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of Tropical department', 'investigatorFullName': 'Hala Maher Abdelhafiz', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-01', 'type': 'RELEASE'}, {'date': '2025-07-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hala Maher Abdelhafeez, resident of Tropical department, Sohag University'}}}}