Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-28 @ 9:02 PM
Study NCT ID:
NCT04857333
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-16
First Post:
2021-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003074', 'term': 'Solitary Pulmonary Nodule'}, {'id': 'D055613', 'term': 'Multiple Pulmonary Nodules'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1800}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to surgical resection', 'timeFrame': 'The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months', 'description': 'Time calculated from the date of identification of pulmonary nodule to the date of surgical resection'}, {'measure': 'Time to progression', 'timeFrame': 'The date of first documented diagnosis of pulmonary nodule by CT scan to the date of documented progression by CT scan, up to 60 months', 'description': 'Time calculated from the date of identification of pulmonary nodule to the date of progression of pulmonary nodule based on evaluation of CT imaging'}], 'secondaryOutcomes': [{'measure': 'Proportion of malignancy', 'timeFrame': 'The date of first documented diagnosis of pulmonary nodule by CT scan to the date of surgical resection, up to 60 months', 'description': 'Proportion of malignant findings by pathological examination in all patients receiving surgical resection'}, {'measure': 'Change of Hospital Anxiety and Depression Scale-Anxiety (HADS-A) score', 'timeFrame': 'The date of enrollment in our cohort study when Hospital Anxiety and Depression Scale is measured to the date when primary endpoint( surgical resection) is reached, up to 60 months, with multiple measurements.', 'description': 'The differences of Hospital Anxiety and Depression Scale-Anxiety (HADS-A) scores of the same patients before and after surgical resection. This 7-item checklist is a part of the Hospital Anxiety and Depression Scale, which is used for assessment for the status of anxiety. The maximal score for HADS-A is 21. Scores of greater than or equal to 11 on either scale indicate a definitive case. Scores of 0-7 are defined to be normal, while scores of 8-10 are defined to be borderline abnormal (borderline case).'}, {'measure': 'Change of Hospital Anxiety and Depression Scale-Depression (HADS-D) score', 'timeFrame': 'The date of enrollment in our cohort study when Hospital Anxiety and Depression Scale is measured to the date when primary endpoint( surgical resection) is reached, up to 60 months, with multiple measurements.', 'description': 'The differences of Hospital Anxiety and Depression Scale-Depression (HADS-D) scores of the same patients before and after surgical resection. This 7-item checklist is a part of the Hospital Anxiety and Depression Scale, which is used for assessment for the status of depression. The maximal score for HADS-D is 21. Scores of greater than or equal to 11 on either scale indicate a definitive case. Scores of 0-7 are defined to be normal, while scores of 8-10 are defined to be borderline abnormal (borderline case).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary nodule', 'Radiologic picture', 'Prospective observatory study', 'Psychological state', 'Decision-making'], 'conditions': ['Pulmonary Nodule, Solitary', 'Pulmonary Nodule, Multiple']}, 'referencesModule': {'references': [{'pmid': '39812961', 'type': 'DERIVED', 'citation': 'Wu J, Zhuang W, Chen R, Xu H, Li Z, Lan Z, Xia X, He Z, Li S, Deng C, Xu W, Shi Q, Tang Y, Qiao G. Impact of surgery versus follow-up on psychological distress in patients with indeterminate pulmonary nodules: A prospective observational study. Qual Life Res. 2025 Apr;34(4):1167-1177. doi: 10.1007/s11136-024-03876-w. Epub 2025 Jan 15.'}, {'pmid': '35399240', 'type': 'DERIVED', 'citation': 'Zhuang W, Tang Y, Xu W, Huang S, Deng C, Chen R, Zhang D, Zeng C, Tian D, Ben X, Lan Z, Wu H, Gao Z, Wang M, Chen Y, Shi Q, Qiao G. Should psychological distress be listed as a surgical indication for indeterminate pulmonary nodules: protocol for a prospective cohort study in real-world settings. J Thorac Dis. 2022 Mar;14(3):769-778. doi: 10.21037/jtd-21-1423.'}]}, 'descriptionModule': {'briefSummary': 'The researchers are aimed to investigate the dynamic evolution of indeterminate pulmonary nodules by a long-term follow-up of patients with different characteristics. Influence factors of clinical decision-making that might contribute to overtreatment or delayed treatment will also be studied.', 'detailedDescription': "This observatory study prospectively recruits patients with indeterminate pulmonary nodules identified in computed tomography (CT) scans from thoracic clinic. The radiological features and their chronological changes during follow-up period will be recorded in detail. Subgroup analyses will be performed based on the clinical and demographic characteristics of patients (including symptomatic information, comorbidities, family history, antibiotic usage, etc). Hospital Anxiety and Depression Scale (HADS) is collected from each patient at multiple time points to evaluate the patients' psychological status and its impact on clinical decision-making. The interaction analyses between individual characteristics (such as education level, occupation, disease cognitive level, etc) and Hospital Anxiety and Depression Scale will also be performed. The researchers aim to provide high-quality evidence for the formulation of a precise follow-up and management plan for patients with pulmonary nodules."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants in this study are diagnosed with solitory or multiple indeterminate pulmonary nodules( ≤ 3cm ), and are willing to be followed-up for continous collection of their related disease information.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with pulmonary nodules ≤ 3cm\n2. Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort\n\nExclusion Criteria:\n\n1. Patients with a surgical history of pulmonary nodules;\n2. Patients who have obtained pathological diagnosis through surgery or non-surgical methods such as puncture;\n3. Patients with pulmonary nodules that are likely metastatic from other sites;\n4. Refuse to participate in this study.'}, 'identificationModule': {'nctId': 'NCT04857333', 'acronym': 'DEPICT', 'briefTitle': 'Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'KY-Q-2021-005-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Nodule', 'description': 'Patients are recommended for using antibiotics, solely follow-up or surgical resection according to the current clinical guideline for management of indeterminate pulmonary nodule. No intervention is administered for this observatory study.', 'interventionNames': ['Diagnostic Test: CT scan', 'Drug: Antibiotics', 'Procedure: Surgical Resection']}], 'interventions': [{'name': 'CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'For patients with low-risk pulmonary nodules, follow-up CT scan is recommended', 'armGroupLabels': ['Pulmonary Nodule']}, {'name': 'Antibiotics', 'type': 'DRUG', 'description': 'For pulmonary nodules with features of infectious disease, antibiotics is recommended', 'armGroupLabels': ['Pulmonary Nodule']}, {'name': 'Surgical Resection', 'type': 'PROCEDURE', 'description': 'For persistent high-risk pulmonary nodules, surgical resection is recommended', 'armGroupLabels': ['Pulmonary Nodule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All individual participant data are strictly protected for patient privacy according to the agreement in Informed Consent Form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GuiBin Qiao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Administrative Director, Department of Thoracic Surgery', 'investigatorFullName': 'GuiBin Qiao', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}