Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT06685458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Constructing a Predictive Model for Differentiating Between Benign and Malignant Solid Pulmonary Nodules Based on Clinical and Imaging Features.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D055613', 'term': 'Multiple Pulmonary Nodules'}], '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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-10', 'studyFirstSubmitDate': '2024-11-10', 'studyFirstSubmitQcDate': '2024-11-10', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of predictive model', 'timeFrame': 'Within 2 years after surgical resection and pathological confirmation', 'description': 'The primary outcome is the area under the receiver operating characteristic curve (AUC) of the predictive model in distinguishing benign from malignant solid pulmonary nodules, based on preoperative clinical and imaging features.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Cancer Screening', 'Nodule Malignancy Prediction', 'Preoperative Imaging Analysis'], 'conditions': ['Lung Cancer', 'Solid Pulmonary Nodules', 'Pulmonary Nodules']}, 'referencesModule': {'references': [{'pmid': '31912902', 'type': 'BACKGROUND', 'citation': 'Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.'}, {'pmid': '26762738', 'type': 'BACKGROUND', 'citation': 'Goldstraw P, Chansky K, Crowley J, Rami-Porta R, Asamura H, Eberhardt WE, Nicholson AG, Groome P, Mitchell A, Bolejack V; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016 Jan;11(1):39-51. doi: 10.1016/j.jtho.2015.09.009.'}, {'pmid': '30207593', 'type': 'BACKGROUND', 'citation': 'Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.'}, {'type': 'BACKGROUND', 'citation': 'Choo E. Testing: High-Resolution Chest Computed Tomography Scan. Springer New York. 2014.'}, {'pmid': '28835992', 'type': 'BACKGROUND', 'citation': 'Yip R, Li K, Liu L, Xu D, Tam K, Yankelevitz DF, Taioli E, Becker B, Henschke CI. Controversies on lung cancers manifesting as part-solid nodules. Eur Radiol. 2018 Feb;28(2):747-759. doi: 10.1007/s00330-017-4975-9. Epub 2017 Aug 23.'}, {'pmid': '16567482', 'type': 'BACKGROUND', 'citation': 'Winer-Muram HT. The solitary pulmonary nodule. Radiology. 2006 Apr;239(1):34-49. doi: 10.1148/radiol.2391050343.'}, {'pmid': '24004118', 'type': 'BACKGROUND', 'citation': 'McWilliams A, Tammemagi MC, Mayo JR, Roberts H, Liu G, Soghrati K, Yasufuku K, Martel S, Laberge F, Gingras M, Atkar-Khattra S, Berg CD, Evans K, Finley R, Yee J, English J, Nasute P, Goffin J, Puksa S, Stewart L, Tsai S, Johnston MR, Manos D, Nicholas G, Goss GD, Seely JM, Amjadi K, Tremblay A, Burrowes P, MacEachern P, Bhatia R, Tsao MS, Lam S. Probability of cancer in pulmonary nodules detected on first screening CT. N Engl J Med. 2013 Sep 5;369(10):910-9. doi: 10.1056/NEJMoa1214726.'}, {'pmid': '24013495', 'type': 'BACKGROUND', 'citation': 'Sim YT, Goh YG, Dempsey MF, Han S, Poon FW. PET-CT evaluation of solitary pulmonary nodules: correlation with maximum standardized uptake value and pathology. Lung. 2013 Dec;191(6):625-32. doi: 10.1007/s00408-013-9500-6. Epub 2013 Sep 8.'}, {'pmid': '31699047', 'type': 'BACKGROUND', 'citation': 'Chu ZG, Zhang Y, Li WJ, Li Q, Zheng YN, Lv FJ. Primary solid lung cancerous nodules with different sizes: computed tomography features and their variations. BMC Cancer. 2019 Nov 7;19(1):1060. doi: 10.1186/s12885-019-6274-0.'}, {'pmid': '30659988', 'type': 'BACKGROUND', 'citation': 'Ye T, Deng L, Wang S, Xiang J, Zhang Y, Hu H, Sun Y, Li Y, Shen L, Xie L, Gu W, Zhao Y, Fu F, Peng W, Chen H. Lung Adenocarcinomas Manifesting as Radiological Part-Solid Nodules Define a Special Clinical Subtype. J Thorac Oncol. 2019 Apr;14(4):617-627. doi: 10.1016/j.jtho.2018.12.030. Epub 2019 Jan 17.'}, {'pmid': '33860370', 'type': 'BACKGROUND', 'citation': 'Sun K, You A, Wang B, Song N, Wan Z, Wu F, Zhao W, Zhou F, Li W. Clinical T1aN0M0 lung cancer: differences in clinicopathological patterns and oncological outcomes based on the findings on high-resolution computed tomography. Eur Radiol. 2021 Oct;31(10):7353-7362. doi: 10.1007/s00330-021-07865-2. Epub 2021 Apr 15.'}, {'type': 'BACKGROUND', 'citation': 'Zhao WJ. Preliminary study on CT radiomics to differentiate tuberculosis, adenocarcinoma, and non-tuberculous infectious lesions manifesting as solid pulmonary nodules or masses. 2024.'}, {'pmid': '27215456', 'type': 'BACKGROUND', 'citation': 'Li M, Han R, Song W, Wang X, Guo F, Su D, Yu T, Wang Y. [Three Dimensional Volumetric Analysis of Solid Pulmonary Nodules on Chest CT: Cancer Risk Assessment]. Zhongguo Fei Ai Za Zhi. 2016 May 20;19(5):279-85. doi: 10.3779/j.issn.1009-3419.2016.05.05. Chinese.'}, {'type': 'BACKGROUND', 'citation': 'Ma X. Development and validation of a combined model based on imaging features and circulating tumor cells for differentiating benign and malignant solid pulmonary nodules. 2024.'}, {'type': 'BACKGROUND', 'citation': 'Zhu LL. Analysis of malignant risk factors and imaging and tumor marker expression characteristics in patients with solitary pulmonary nodules. 2022.'}]}, 'descriptionModule': {'briefSummary': 'Study Objective:\n\nTo comprehensively analyze the preoperative clinical and imaging characteristics of solid pulmonary nodules, investigate the risk factors associated with malignant solid pulmonary nodules, and provide a reference for preoperative treatment decisions.\n\nSignificance of the Study:\n\nAccording to the 2020 Global Cancer Report, lung cancer remains the leading cause of cancer-related deaths worldwide. While the majority of patients with stage I lung cancer achieve long-term survival, survival rates for advanced-stage patients are extremely low. Early screening, diagnosis, and treatment of lung cancer are crucial.\n\nWith the widespread implementation of early lung cancer screening, a growing number of pulmonary nodules are being detected, among which solid pulmonary nodules constitute a significant proportion. Unlike ground-glass nodules, accurately distinguishing between benign and malignant solid nodules is critical for determining appropriate treatment strategies. For benign solid nodules, follow-up observation is the preferred approach, whereas early surgical intervention is essential for malignant solid nodules.\n\nAlthough previous studies have explored the correlation between clinical and imaging characteristics, they have not conducted systematic analyses, and most have been based on small sample sizes. Therefore, this study aims to conduct a comprehensive analysis of preoperative clinical and imaging characteristics, build a predictive model to differentiate between benign and malignant solid pulmonary nodules, and provide a reliable reference for selecting treatment strategies.', 'detailedDescription': 'Our study evaluate patients with SPN from the Third Affiliated Hospital of Kunming Medical University. The patient selection followed specific inclusion and exclusion criteria. Inclusion criteria included: (1) All subjects provided CT imaging obtained from the Third Affiliated Hospital of Kunming Medical University within 2-week period prior to surgery; (2) Complete clinicopathological data of solid nodules were obtained; (3) Surgical intervention for one or more SPN; (4) No prior anti-tumor treatments like radiotherapy or chemotherapy; (5) Age 18 years or older. Exclusion criteria involved: (1) Patients with incomplete imaging data or medical records; (2) Lung infections that could affect image analysis; (3) Significant respiratory movement artifacts in images impairing imaging analysis; (4) Inconsistent locations of SPN in postoperative pathology reports and preoperative CT images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes patients aged 18 years and older with radiologically diagnosed solid pulmonary nodules. These patients are undergoing preoperative clinical and imaging evaluations and subsequent surgical resection to confirm the benign or malignant nature of the nodules', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) All subjects provided CT imaging obtained from the Third Affiliated Hospital of Kunming Medical University within 2-week period prior to surgery; (2) Complete clinicopathological data of solid nodules were obtained; (3) Surgical intervention for one or more SPN; (4) No prior anti-tumor treatments like radiotherapy or chemotherapy; (5) Age 18 years or older.\n\nExclusion Criteria:\n\n* (1) Patients with incomplete imaging data or medical records; (2) Lung infections that could affect image analysis; (3) Significant respiratory movement artifacts in images impairing imaging analysis; (4) Inconsistent locations of SPN in postoperative pathology reports and preoperative CT images.'}, 'identificationModule': {'nctId': 'NCT06685458', 'briefTitle': 'Constructing a Predictive Model for Differentiating Between Benign and Malignant Solid Pulmonary Nodules Based on Clinical and Imaging Features.', 'organization': {'class': 'OTHER', 'fullName': 'The Third Affiliated Hospital of Kunming Medical College.'}, 'officialTitle': 'Combined With Clinical and Imaging Features, the Prediction Model of Benign and Malignant Solid Pulmonary Nodules Was Constructed', 'orgStudyIdInfo': {'id': 'KYLX2024-271'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Benign Nodule Group', 'description': 'Participants with benign solid pulmonary nodules.', 'interventionNames': ['Other: Preoperative Clinical and Imaging Feature Evaluation for Predictive Modeling']}, {'label': 'Malignant Nodule Group', 'description': 'Participants with malignant solid pulmonary nodules.', 'interventionNames': ['Other: Preoperative Clinical and Imaging Feature Evaluation for Predictive Modeling']}], 'interventions': [{'name': 'Preoperative Clinical and Imaging Feature Evaluation for Predictive Modeling', 'type': 'OTHER', 'description': 'This study involves preoperative evaluation of clinical and imaging features for constructing a predictive model to differentiate benign and malignant solid pulmonary nodules. Surgical resection is performed to obtain pathological confirmation as the reference standard.', 'armGroupLabels': ['Benign Nodule Group', 'Malignant Nodule Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'yantao yang', 'role': 'CONTACT', 'email': '2443804244@qq.com', 'phone': '18288509115'}, {'name': 'lianhua ye', 'role': 'CONTACT', 'email': 'Lhye1204@aliyun.com', 'phone': '13769123627'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets generated and/or analyzed during the current study are not publicly available due sharing data is not included in our research institution review board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Third Affiliated Hospital of Kunming Medical College.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Yantao Yang', 'investigatorAffiliation': 'The Third Affiliated Hospital of Kunming Medical College.'}}}}