Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-02 @ 1:01 PM
Study NCT ID:
NCT06842056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multinational Observational Study to Describe Diagnostic Stage Shift in Patients With Lung Cancer Using Medical Records
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age categories', 'timeFrame': '5 years', 'description': 'Relationship between the diagnosis at early stage and following characteristics - Age categories'}, {'measure': 'smoking categories.', 'timeFrame': '5 years', 'description': 'Relationship between the diagnosis at early stage with smoking categories'}], 'primaryOutcomes': [{'measure': 'Early stage (stage I and II with [N0])', 'timeFrame': '5 years', 'description': 'Number and percentage of patients diagnosed with Early stage (stage I and II with \\[N0\\]) from baseline year until EOS'}, {'measure': 'Locally advanced (stage II and III [N+])', 'timeFrame': '5 years', 'description': 'Number and percentage of patients diagnosed with Locally advanced (stage II and III \\[N+\\]) from baseline year until EOS'}, {'measure': 'Late stage (stage IV [M1])', 'timeFrame': '5 years', 'description': 'Number and percentage of patients diagnosed with Late stage (stage IV \\[M1\\]) from baseline year until EOS'}], 'secondaryOutcomes': [{'measure': 'screening based on clinical presentation', 'timeFrame': '5 years', 'description': 'Number and percentage of patients with modalities of diagnosis and screening at the yearly data cut-off based on clinical presentation'}, {'measure': 'Incidental diagnosis', 'timeFrame': '5 years', 'description': 'Number and percentage of patients with Incidental diagnosis o Through screening program (Yes/No) If yes, screening modality (LDCT/ sputum microscopy/ chest X-ray/ any other)'}, {'measure': 'TNM staging', 'timeFrame': '5 years', 'description': 'Number and percentage of patients presenting with TNM staging according to AJCC 8th edition (Aberle, 2011;Kutob, 2019) or staging by alternative lung cancer staging system'}, {'measure': 'Histological type', 'timeFrame': '5 years', 'description': 'Number and percentage of patients presenting with lung cancer diagnosis. Histological type'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'Aggregate data', 'Non small cell lung cancer', 'data extraction', 'Early stage', 'Locally advanced', 'Late stage'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Multinational observational study to describe diagnostic stage shift in patients with lung cancer using medical records. Increased lung cancer screening programs and increased utilization of other screening modalities such as large increase in community chest radiography referral rates in response to public awareness campaigns, as well as unintentional detections through cardiac CT(computed tomography) angiograms, or screening for coronary disease may help in detecting the disease at earlier curable stages. Availability and increased access to novel therapies increase the likelihood of an early-stage diagnosis aiming for improved survival.', 'detailedDescription': 'This is a multicentric, multinational, observational study to describe the shift in stage at diagnosis of lung cancer over the time- period from baseline year to EOS (end of study). The study will be implemented in the AstraZeneca International Region (ie, non-US, non-European countries). The participating countries and sites will be selected based on the availability and accessibility of secondary data sources such as lung cancer databases or EMR (electronic medical records) in the target countries. Once countries and databases are selected, the protocol will be adapted for the specific country including details about the patient databases. The study will be conducted in compliance with the local legal, ethical, and regulatory requirements of the selected countries. The study-specific data will be extracted from the databases and recorded using eCRF (electronic case report form). This study does not involve direct recruitment of the patients. Aggregated data from the databases for each consecutive year starting from the baseline year until EOS, of patients with lung cancer meeting the inclusion criteria will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study does not involve direct recruitment of the patients. Aggregated data from the databases for each consecutive year starting from the baseline year until End of study. Patients with lung cancer meeting the following criteria will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female and male patients ≥18 years old.\n* Confirmed diagnosis of lung cancer (either cytologically or histologically)\n\nExclusion Criteria:\n\n* Patients presenting with recurrent or relapsed lung cancer.\n* Patients with a concomitant cancer at the time of diagnosis of lung cancer, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms: a cancer will be considered concomitant if it occurs within 5 years of lung cancer diagnosis.'}, 'identificationModule': {'nctId': 'NCT06842056', 'acronym': 'DIASTAG', 'briefTitle': 'Multinational Observational Study to Describe Diagnostic Stage Shift in Patients With Lung Cancer Using Medical Records', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Multicentric Multinational Observational Study to Describe the Shift in Stage at Diagnosis of Lung Cancer. No Direct Recruitment of Patients or Administration of Study Medication.', 'orgStudyIdInfo': {'id': 'D133HR00049'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.\n\nSigned Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}