Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-01 @ 9:01 PM
Study NCT ID:
NCT07070557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Neutrophil-to-Lymphocyte Ratio and Patients With Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 months', 'description': 'The primary outcome measures in the study "High Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio Are Associated with Poor Survival in Patients with Hemodialysis" is :- All-cause mortality, encompassing death from any cause These is the endpoint used to evaluate the prognostic significance of NLR and PLR in hemodialysis patients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemodialysis Patient']}, 'descriptionModule': {'briefSummary': 'To explore the role of neutrophil-to-lymphocyte ratio ( NLR ) and platelet-to-lymphocyte ratio ( PLR ) in predicting mortality in hemodialysis (HD) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients on regular hemodialysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All cases with age ≥ 18 years from both sexes female and male, having end-stage renal disease (ESRD), who have been on hemodialysis for at least three months and divided to 4 groups according to the median of NLR and PLR\n\nExclusion Criteria:\n\n* • Patients aged \\< 18 years old.\n\n * Patient with autoimmune disease.\n * Patient with liver cirrhosis.\n * Patients with immunodeficiency.\n * Patients with malignancy.'}, 'identificationModule': {'nctId': 'NCT07070557', 'briefTitle': 'High Neutrophil-to-Lymphocyte Ratio and Patients With Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'High Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio Are Associated With Poor Survival in Patients With Hemodialysis', 'orgStudyIdInfo': {'id': 'Soh-Med--25-6-10MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'neutrophil lymphocyte ratio and platelet lymphocyte ratio', 'type': 'OTHER', 'description': 'explore the role of neutrophil-to-lymphocyte ratio ( NLR ) and platelet-to-lymphocyte ratio ( PLR ) in predicting mortality in hemodialysis (HD) patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'state': 'Sohag Governorate', 'country': 'Egypt', 'contacts': [{'name': 'ali taha, professor of internal medicine', 'role': 'CONTACT', 'email': 'alitaha23222@gmail.com', 'phone': '01005871047'}, {'name': 'marwa zanaty, lecture of internal medicine', 'role': 'CONTACT', 'phone': '01007100970'}], 'facility': 'Hemodialysis Unit', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident in internal medicine department', 'investigatorFullName': 'Bassem Ayman Mohamed', 'investigatorAffiliation': 'Sohag University'}}}}