Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-04 @ 3:16 AM
Study NCT ID:
NCT03338166
Status:
UNKNOWN
Last Update Posted:
2017-11-09
First Post:
2017-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of LDH as a Predictor of Treatment Outcomes in Hepatocellular Carcinoma
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': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-07', 'studyFirstSubmitDate': '2017-06-17', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum LDH level as a predictor of response in hepatocellular carcinoma', 'timeFrame': '2 months', 'description': 'To evaluate if serum LDH level can be used as a predictor of response in patients receiving different lines of treatment for hepatocellular carcinoma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma represents the commonest primary cancer of the liver.serum lactate dehydrogenase is an indirect marker of tumor hypoxia,angioneogenesis and worse prognosis.', 'detailedDescription': 'Hepatocellular carcinoma (HCC) represents the commonest primary cancer of the liver. Incidence is increasing and HCC has risen to become the 5th commonest malignancy worldwide and the third leading cause of cancer related death, exceeded only by cancers of the lung and stomach. HCC prevalence is higher in sub-Saharan Africa, central and Southeast Asia.Serum lactate dehydrogenase (LDH) levels is an indirect marker of tumor hypoxia, angioneogenesis and worse prognosis. Lactic dehydrogenase (LDH), which is a glycolytic enzyme, composed of four polypeptide chains, each one encoded by separate gene (M and H), exists in various types of human tissue and neoplasms. LDH is a key enzyme in the conversion pyruvate to lactate under anaerobic conditions .Five isoforms of LDH have been identified as a result of the five different combinations of polypeptide subunits.\n\nHypoxia represents a clinical biological mechanism for treatment resistance in cancer cells via the formation of new blood vessels. Furthermore, a growing body of evidence indicates that hypoxia might actually promote cancer development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients resident at oncology department at luxor international hospital who diagnosed as apatient with Hepatocellular carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with Hepatocellular carcinoma diagnosed by biopsy or imaging criteria and alpha feto protein.\n* signed informed consent before registration in study\n* Eastern Cooperative oncology Groups Performance status between 0 and 2.\n\nExclusion Criteria:\n\n* Cachexia or poor condition\n* pregnant or human chorionic gonadotropin positive\n* patient with another liver tumor\n* Any previous treatment'}, 'identificationModule': {'nctId': 'NCT03338166', 'briefTitle': 'Role of LDH as a Predictor of Treatment Outcomes in Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of LDH as a Predictor of Treatment Outcomes in Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'URL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients with Hepatocellular carcinoma who treated with sorafenib and measure LDH serum level one month pre and post treatment', 'interventionNames': ['Other: LDH serum level']}, {'label': 'Group B', 'description': 'Patients with Hepatocellular carcinoma who treated with trans catheter arterial chemo embolization (TACE) and measure LDH serum level one month pre and post treatment', 'interventionNames': ['Other: LDH serum level']}, {'label': 'Group C', 'description': 'Patients with Hepatocellular carcinoma who treated surgically and measure LDH serum level one month pre and post treatment', 'interventionNames': ['Other: LDH serum level']}, {'label': 'Group D', 'description': "Patients with Hepatocellular carcinoma who don't receive treatment and asses LDH serum level for 3months", 'interventionNames': ['Other: LDH serum level']}], 'interventions': [{'name': 'LDH serum level', 'type': 'OTHER', 'description': 'Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Samir S Mohammed, Professor', 'role': 'CONTACT', 'email': 'samir_eid@hotmail.com', 'phone': '00201222302375'}, {'name': 'Marwa I Khalaf, Lecturer', 'role': 'CONTACT', 'email': 'esmail_marwa@yahoo.com', 'phone': '00201201777338'}], 'overallOfficials': [{'name': 'Aml R Ibrahim, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nourhan Yousef', 'investigatorAffiliation': 'Assiut University'}}}}