Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-25 @ 2:36 AM
Study NCT ID:
NCT03749512
Status:
COMPLETED
Last Update Posted:
2018-11-21
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NLCR in Prediction of the Grade of Lung Tumor.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001772', 'term': 'Blood Cell Count'}], 'ancestors': [{'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2018-11-16', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil-lymphocyte count ratio', 'timeFrame': 'From October 1, 2014 to October 15, 2018', 'description': 'Neutrophil-lymphocyte count ratio is measured during routine preoperative blood tests.'}], 'secondaryOutcomes': [{'measure': 'Neutrophil count', 'timeFrame': 'From October 1, 2014 to October 15, 2018', 'description': 'Neutrophil count is measured during routine preoperative blood tests.'}, {'measure': 'Lymphocyte count', 'timeFrame': 'From October 1, 2014 to October 15, 2018', 'description': 'Lymphocyte count is measured during routine preoperative blood tests.'}, {'measure': 'Leucocyte count', 'timeFrame': 'From October 1, 2014 to October 15, 2018', 'description': 'Leucocyte count is measured during routine preoperative blood tests.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NLCR, The neutrophil-lymphocyte count ratio, Lung Neoplasm'], 'conditions': ['Lung Neoplasm']}, 'descriptionModule': {'briefSummary': "The aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from the routine preoperative blood test may predict lung tumors' grading.", 'detailedDescription': "Lung cancer remains as one of the leading causes of death among oncology patients. Close connection between inflammation and pathogenesis of some neoplasms was determined in a number of studies. Some studies show promise that ratio of neutrophil to lymphocyte count (NLCR) may be recognized as a prognostic marker for several carcinomas: renal, lung and colorectal. The aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from the routine preoperative blood test may predict lung tumors' grading. During routine preoperative blood tests complete blood count is done and NLCR, WBC, neutrophil and lymphocyte count is noted. After the thoracic surgery intervention and histopathological examination grading of lung tumor is noted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive thoracic surgery patients admitted to SPSK nr 1 in Zabrze between October 2014 and October 2018 with lung tumor qualified for thoracic surgery intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consecutive thoracic surgery patients with lung cancer grading confirmed by histopathology postoperatively\n* preoperative routine complete blood count analysis\n\nExclusion Criteria:\n\n* infectious disease\n* pregnancy\n* autoimmunologic disease\n* other known conditions or treatments that may influence the blood count (seropositivity for HIV, chemotherapy, and corticotherapy)'}, 'identificationModule': {'nctId': 'NCT03749512', 'briefTitle': 'NLCR in Prediction of the Grade of Lung Tumor.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Preoperative Neutrophil-lymphocyte Count Ratio in Prediction of the Grade of Lung Tumor.', 'orgStudyIdInfo': {'id': 'NLCR-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational Group', 'description': 'Group of patients with lung tumor qualified for thoracic surgery intervention with routine, preoperative complete blood count test and routine postoperative histopathological examination of lung tumor.', 'interventionNames': ['Diagnostic Test: Complete blood count', 'Other: Histopathological examination']}], 'interventions': [{'name': 'Complete blood count', 'type': 'DIAGNOSTIC_TEST', 'description': 'During routine preoperative blood test complete blood count is taken.', 'armGroupLabels': ['Observational Group']}, {'name': 'Histopathological examination', 'type': 'OTHER', 'description': 'Routine postoperative histopathological examination of lung tumor.', 'armGroupLabels': ['Observational Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny nr 1', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'overallOfficials': [{'name': 'Hanna Misiołek, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Silesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Piotr Palaczyński', 'investigatorAffiliation': 'Medical University of Silesia'}}}}