Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-03 @ 1:19 PM
Study NCT ID:
NCT07003204
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2025-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neutrophil-to Lymphocyte and Monocyte-to-Lymphocyte Ratios in Exudative Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MLR and NLR measuring in pleural fluid', 'timeFrame': 'one month', 'description': 'counting the pleural monocytes, neutrophils and lymphoctes'}], 'primaryOutcomes': [{'measure': 'MLR and NLR measuring in pleural fluid', 'timeFrame': '1 month', 'description': 'counting pleural fluid monocytes,lymphocytes and neutrophils'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effusion']}, 'referencesModule': {'availIpds': [{'id': 'msabry776@yahoo.com', 'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC8075197/', 'type': 'Clinical Study Report', 'comment': 'very good'}], 'seeAlsoLinks': [{'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC8075197/', 'label': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC8075197/'}]}, 'descriptionModule': {'briefSummary': 'Exudative pleural effusion (EPE) presents a diagnostic challenge, requiring accurate biomarkers to predict outcomes and guide treatment. The neutrophil-to-lymphocyte ratio (NLR) and monocyte-to-lymphocyte ratio (MLR) in pleural fluid are emerging as potential prognostic markers. We aimed to assess the diagnostic and prognostic utility of pleural fluid NLR and MLR in EPE.', 'detailedDescription': 'Pleural fluid NLR and MLR are reliable biomarkers for diagnosing malignant pleural effusion and predicting poorer survival outcomes. These ratios may be useful in clinical practice, especially in resource-limited settings, to guide decision-making in the management of pleural effusions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 person with pleural effusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients aged 18-80 years with an EPE diagnosis confirmed by thoracentesis.\n\nExclusion Criteria:\n\n* Exclusion criteria included patients with a history of recent surgery, corticosteroid use, or those with mixed effusion types.'}, 'identificationModule': {'nctId': 'NCT07003204', 'briefTitle': 'Neutrophil-to Lymphocyte and Monocyte-to-Lymphocyte Ratios in Exudative Pleural Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Diagnostic and Prognostic Role of Pleural Fluid Neutrophil-to Lymphocyte and Monocyte-to-Lymphocyte Ratios in Exudative Pleural Effusion', 'orgStudyIdInfo': {'id': 'lymphocyte- monocyte- exudate'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'only one group of patients', 'description': 'prospective cohort randomized control study', 'interventionNames': ['Procedure: medical thoracoscopy']}], 'interventions': [{'name': 'medical thoracoscopy', 'type': 'PROCEDURE', 'description': 'pleural fluid aspiration and cellular analysis', 'armGroupLabels': ['only one group of patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Alexandria', 'state': 'Egypt', 'country': 'Egypt', 'facility': 'Chest Department -Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'mohamed Sabry eltarhony, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not in the policy of the department'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of chest diseases', 'investigatorFullName': 'Mohamed Sabry', 'investigatorAffiliation': 'Alexandria University'}}}}