Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-06-03 @ 6:53 PM
Study NCT ID:
NCT04352335
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil to lymphocyte ratio (NLR)', 'timeFrame': 'Baseline, 4~8 week'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neutrophil to lymphocyte ratio (NLR)', 'immunomodulator'], 'conditions': ['Advanced Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (NLR) after 6-week treatment of immune checkpoint inhibitors (ICIs) with or without immunomodulatory drugs and recognize the effect of post-treatment NLR and overall survival in advanced lung cancer patients by retrospective review.', 'detailedDescription': 'In recent years, the therapeutic strategies for lung cancer have been enriched with small molecular targeted therapy and immunotherapy. In this retrospective study, we will observe the change in NLR and explore its possible association with survival among advanced lung cancer patients receiving Immune checkpoint inhibitors (ICIs) with and without such immuno-modulator, Astragalus Polysaccharide Injection. It can be used to understand the relationship between NLR values and the survival rate of lung cancer patients after ICIs treatment. Physicians can refer to this result to give patients the suitable treatment recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lung cancer undergoing ICIs with or without immunomodulatory drug', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Aged 20 years and older.\n* Patients who have been given a diagnosis of lung cancer.\n* Previously advanced lung cancer patients first treated with ICIs from Oct 1, 2015 to Oct 31, 2019.\n\nExclusion Criteria\n\n* Patients who have no hematological laboratory data available at baseline (within 3 days prior to ICI treatment) and the 6th week (± 2 weeks) after ICI treatment initiation.'}, 'identificationModule': {'nctId': 'NCT04352335', 'briefTitle': 'Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Change in Neutrophil to Lymphocyte Ratio (NLR) and Survival Among Advanced Lung Cancer Patients Receiving Immune Checkpoint Inhibitors With Immunomodulator: a Retrospective Study', 'orgStudyIdInfo': {'id': 'CSMUH02-NLR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1：ICI treatment with immunomodulator', 'description': 'Lung cancer patients received immunological checkpoint inhibitors (ICIs) and any immunomodulatory drugs.'}, {'label': 'Cohort 2：ICI treatment without immunomodulator', 'description': 'Lung cancer patients received immunological checkpoint inhibitors (ICIs).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Shih-Ming TSAI, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'LJ Hwu', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}