Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT03535766
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Analysis of Treatment Timelines for Lung Cancer Patients Across System Evolutions
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from presentation to treatment', 'timeFrame': 'from initial patient presentation with symptoms or incidental finding to first day of treatment, up to 3 years', 'description': 'Time from initial patient presentation with symptoms or incidental finding to first day of treatment, measured in days.'}], 'secondaryOutcomes': [{'measure': 'Additional time between imaging and physician referrals', 'timeFrame': 'From identification of concerning nodule to specialist appointment, up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '21610526', 'type': 'BACKGROUND', 'citation': 'Diaconescu R, Lafond C, Whittom R. Treatment delays in non-small cell lung cancer and their prognostic implications. J Thorac Oncol. 2011 Jul;6(7):1254-9. doi: 10.1097/JTO.0b013e318217b623.'}, {'pmid': '26543688', 'type': 'BACKGROUND', 'citation': 'Van de Vosse D, Chowdhury R, Boyce A, Halperin R. Wait Times Experienced by Lung Cancer Patients in the BC Southern Interior to Obtain Oncologic Care: Exploration of the Intervals from First Abnormal Imaging to Oncologic Treatment. Cureus. 2015 Sep 22;7(9):e330. doi: 10.7759/cureus.330.'}, {'pmid': '27143146', 'type': 'BACKGROUND', 'citation': 'Vidaver RM, Shershneva MB, Hetzel SJ, Holden TR, Campbell TC. Typical Time to Treatment of Patients With Lung Cancer in a Multisite, US-Based Study. J Oncol Pract. 2016 Jun;12(6):e643-53. doi: 10.1200/JOP.2015.009605. Epub 2016 May 3.'}]}, 'descriptionModule': {'briefSummary': 'This study is a single center, minimal risk, physician initiated retrospective chart review. An analysis of treatment timelines for patients diagnosed with lung cancer within the St. Elizabeth system from January 2013 until study completion. The study investigator and designee(s) will review patient electronic medical records, extracting data related to the symptom presentation, diagnosis, and treatment of new diagnoses of lung cancer. Collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments, with data analysis evaluating time between care encounters and potential delays in care. The data will be further stratified based on system-wide changes implemented to improve efficiency, patient outcomes, and patient experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with lung cancer within the St. Elizabeth system from January 2013 until study completion.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient seen within the St. Elizabeth system\n* \\>=18 years of age\n* New diagnosis of histologically or cytologically documented primary lung cancer diagnosed January 2013 or later\n\nExclusion Criteria:\n\n* Patients with metastatic lung disease of other primary\n* Other malignancies at investigator's discretion\n* Patient received treatment at a facility outside of St. Elizabeth where records are not available through EPIC\n* Patient currently undergoing treatment for new diagnosis of lung cancer"}, 'identificationModule': {'nctId': 'NCT03535766', 'acronym': 'TRACE', 'briefTitle': 'An Analysis of Treatment Timelines for Lung Cancer Patients Across System Evolutions', 'organization': {'class': 'OTHER', 'fullName': 'St Elizabeth Healthcare'}, 'officialTitle': 'An Analysis of Treatment Timelines for Lung Cancer Patients Across System Evolutions', 'orgStudyIdInfo': {'id': '2/2018-014'}}, 'contactsLocationsModule': {'locations': [{'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'St. Elizabeth Healthcare', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}], 'overallOfficials': [{'name': 'Royce Calhoun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Elizabeth Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St Elizabeth Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}