Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-04 @ 6:52 PM
Study NCT ID:
NCT05441202
Status:
UNKNOWN
Last Update Posted:
2022-07-01
First Post:
2022-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Nodule Intervention Cohort Study
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': 10000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2022-06-28', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of lung nodule size', 'timeFrame': 'three months minimal', 'description': 'change of lung nodule size before and after intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Incident Lung Nodule']}, 'descriptionModule': {'briefSummary': 'Incident lung nodule is quite common in China. The major treatment method is long-term floolow up without a specific intervention. We aim to investigate the efficacy an safty of a novel transdermal therapy with Chinese herb. The study included two arms: one arm is routine treatment and another arm is routine treatment plus transdermal therapy. The study end point is the change of lung nodule size under CT scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'any patient with incident lung nodule after health check up', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incident lung nodule patients\n\nExclusion Criteria:\n\n* severe baseline conditions'}, 'identificationModule': {'nctId': 'NCT05441202', 'acronym': 'LNICS', 'briefTitle': 'Lung Nodule Intervention Cohort Study', 'organization': {'class': 'NETWORK', 'fullName': 'Chinese Chronic Respiratory Disease Research Network'}, 'officialTitle': 'The Efficacy of Transdermal Therapy for Lung nodule---an Real Word Observational Study', 'orgStudyIdInfo': {'id': 'LN002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transdermal therapy', 'type': 'DEVICE', 'description': 'transdermal therapy with Chinese medicine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'XIAOHONG LIU, MD', 'role': 'CONTACT'}], 'facility': 'Guang An Men Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'xiaohong liu, MD', 'role': 'CONTACT', 'email': '18364166279@163.com', 'phone': '+8618364166279'}, {'name': 'Guangxi Li', 'role': 'CONTACT', 'email': 'li.guangxi@mayo.edu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Chronic Respiratory Disease Research Network', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}