Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-24 @ 4:41 PM
Study NCT ID:
NCT03869151
Status:
UNKNOWN
Last Update Posted:
2019-04-02
First Post:
2019-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pretreatment Lymphocyte Monocyte Ratio on Outcome HCC Patients
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': 1}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-31', 'studyFirstSubmitDate': '2019-03-07', 'studyFirstSubmitQcDate': '2019-03-07', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'increased over all survival', 'timeFrame': '1 year', 'description': 'Elevated pretreatment lymphocyte monocyte ratio may be a favorable prognostic factor for clinical outcomes in patients with hepatocellular carcinoma.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To assess the prognostic role of pretreatment LMR in hepatocellular carcinoma(HCC).', 'detailedDescription': 'The exact molecular mechanisms responsible for the prognostic impact of lymphocyte monocyte ratio in Heatocellular carcinoma are unclear.It has been suggested that cross-talk between the inflammatory response and tumor progression play a critical role in the initiation and progression of Heatocellular carcinoma. In the tumor microenvironment, inflammatory infiltrates have a large influence on the biological behavior of Heatocellular carcinoma.\n\nTumor-infiltrating lymphocytes, as representative component of the immune microenvironment ,are implicated in several stages of Heatocellular carcinoma progression, and Tumor-infiltrating lymphocytes phenotypes may be a predictor for favorable prognosis.\n\nConversely, low lymphocyte counts might result in an insufficient immunological reaction, which lead to inferior survival in multiple cancers.\n\nMonocytes infiltrating tumor tissue are also involved in Heatocellular carcinoma development and progression. Activated monocytes in Heatocellular carcinoma micro environments can trigger and polarize T-cell responses and facilitate inflammation-induced tumor development.\n\nTumor-associated macrophages are derived from circulating monocytes. Tumor-associated macrophages can accelerate Heatocellular carcinoma cell proliferation,tumor-associated angiogenesis, and metastasis. Several studies showed that high infiltration of Tumor-associated macrophages predicted decreased survival in various cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hepatocellular carcinoma patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with child A Hepatocellular carcinoma.\n\nExclusion Criteria:\n\n* Patients with child C Hepatocellular carcinoma.\n* Patients with heart failure'}, 'identificationModule': {'nctId': 'NCT03869151', 'briefTitle': 'Pretreatment Lymphocyte Monocyte Ratio on Outcome HCC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Impact of Pretreatment Lymphocyte to Monocyte Ratio on Clinical Outcome for Patient With HCC', 'orgStudyIdInfo': {'id': '17200000'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CBC', 'type': 'DIAGNOSTIC_TEST', 'description': 'lymphocyte and monocyte count'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'amany Amin, master', 'role': 'CONTACT', 'email': 'dr.ma777moud@gmail.com', 'phone': '+201093930042'}], 'overallOfficials': [{'name': 'taha mahran, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'ola abdelfatah, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'aml ebraheem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'amany amin, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amany Aboalenen Amin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amany Aboalenen Amin', 'investigatorAffiliation': 'Assiut University'}}}}