Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-01-10 @ 1:59 AM
Study NCT ID:
NCT03350802
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procalcitonin Test for Differentiation of the Cause of Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 649}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2017-11-17', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procalcitonin level according to the cause of pneumonia in patients with cancer', 'timeFrame': 'procalcitonin level is checked within 24hours after visiting hospital', 'description': 'bacterial pneumonia vs. radiation pneumonitis vs chemotherapy-induced pneumonitis'}], 'secondaryOutcomes': [{'measure': 'Influence of neutropenia on procalcitonin level in patients with baterial pneumonia', 'timeFrame': 'procalcitonin level is checked within 24hours after visiting hospital', 'description': 'bacterial pneumonia with neutropenia vs. without neutropenia'}, {'measure': 'procalcitonin level in patients with atypical pneumonia', 'timeFrame': 'procalcitonin level is checked within 24hours after visiting hospital', 'description': 'viral pneumonia vs tuberculosis vs fungal infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Procalcitonin', 'Pneumonia', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the usefulness of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.', 'detailedDescription': 'Serum procalcitonin test is currently used as the biomarker for bacterial infection. Especially, procalcitonin test has been reported to be helpful in differentiating bacterial pneumonia from viral pneumonia, acute exacerbations of interstitial pneumonitis or chronic obstructive lung disease. However, it is not known whether procalcitonin test can help distinguish bacterial pneumonia from non-bacterial pneumonia such as radiation pneumonitis or chemotherapy-induced pneumonitis in patients with cancer.\n\nThe aim of this prospective cohort study is to observe the clinical benefits of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort.\n\n * suspected symptom: cough, sputum, dyspnea or fever/chill\n * suspected image findings: consolidation or ground-glass opacity on chest radiograph or CT\n2. All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test.\n\n * basic microbiological test: blood culture, sputum gram stain/culture, pneumococcal urinary antigen, legionella urinary antigen, mycoplasma antibody etc.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years\n* Patients who have symptoms and suspected imaging findings compatible with pneumonia\n\nExclusion Criteria:\n\n* Patients who have been treated with antibiotics or steroid therapy.'}, 'identificationModule': {'nctId': 'NCT03350802', 'briefTitle': 'Procalcitonin Test for Differentiation of the Cause of Pneumonia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Usefulness of Procalcitonin Test to Differentiate the Cause of Pneumonia in Patients With Cancers', 'orgStudyIdInfo': {'id': 'NCC2014-0018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'procalcitonin pneumonia cohort', 'description': 'Patients who are suspected of acute pneumonia due to symptoms and imaging findings compatible with pneumonia can be enrolled in this cohort.', 'interventionNames': ['Diagnostic Test: procalcitonin test']}], 'interventions': [{'name': 'procalcitonin test', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test.', 'armGroupLabels': ['procalcitonin pneumonia cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Respiratory Clinic, National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'HEE SEOK LEE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pulmonologist', 'investigatorFullName': 'Hee Seok Lee', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}