Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT06644820
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Outcome of Patients Xith Spontaneous Pneumothorax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of hospital stay', 'timeFrame': '1 year', 'description': 'hospitalization time of patients with spontanous pneumothorax from addmission to discharge from hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spontaneous Pneumothorax']}, 'referencesModule': {'references': [{'pmid': '31613151', 'type': 'BACKGROUND', 'citation': 'Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.'}, {'pmid': '23218593', 'type': 'BACKGROUND', 'citation': 'Hilliard NJ, Marciniak SJ, Babar JL, Balan A. Evaluation of secondary spontaneous pneumothorax with multidetector CT. Clin Radiol. 2013 May;68(5):521-8. doi: 10.1016/j.crad.2012.10.008. Epub 2012 Dec 5.'}, {'pmid': '32010723', 'type': 'BACKGROUND', 'citation': 'Khusial RJ, Honkoop PJ, van der Meer V, Snoeck-Stroband JB, Sont JK. Validation of online Asthma Control Questionnaire and Asthma Quality of Life Questionnaire. ERJ Open Res. 2020 Jan 27;6(1):00289-2019. doi: 10.1183/23120541.00289-2019. eCollection 2020 Jan.'}, {'pmid': '19949733', 'type': 'BACKGROUND', 'citation': 'Noh TJ, Lee CH, Kang YA, Kwon SY, Yoon HI, Kim TJ, Lee KW, Lee JH, Lee CT. Chest computed tomography (CT) immediately after CT-guided transthoracic needle aspiration biopsy as a predictor of overt pneumothorax. Korean J Intern Med. 2009 Dec;24(4):343-9. doi: 10.3904/kjim.2009.24.4.343. Epub 2009 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'Pneumothorax occurs when air accumulates between the visceral and parietal pleura, and canbe defined as spontaneous, iatrogenic or traumatic. Spontaneous pneumothorax further classified as primary or secondary. Primary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking. Secondary spontaneous pneumothorax (SSP) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer,and interstitial lung diseases (ILDs) in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital\n\nExclusion Criteria:\n\n* Patients with traumatic or iatrogenic pneumothorax.'}, 'identificationModule': {'nctId': 'NCT06644820', 'briefTitle': 'Clinical Characteristics and Outcome of Patients Xith Spontaneous Pneumothorax', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Clinical Characteristics and Outcome of Patients Xith Spontaneous Pneumothorax', 'orgStudyIdInfo': {'id': 'Soh-Med-24-09-14MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary spontaneous pneumothorax', 'description': 'Primary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking.', 'interventionNames': ['Diagnostic Test: radiology']}, {'label': 'Secondary spontaneous pneumothorax', 'description': 'Secondary spontaneous pneumothorax (SSP) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer, and interstitial lung diseases (ILDs) in older adults.', 'interventionNames': ['Diagnostic Test: radiology']}], 'interventions': [{'name': 'radiology', 'type': 'DIAGNOSTIC_TEST', 'description': 'Chest x ray posteroanterior view and lateral view.\n\nCT. chest without contrast:\n\nTo assess the underlying lung pathology e.g. multiple bullae, interstitial lung disease (ILD) , cavitating lesions or nodules.', 'armGroupLabels': ['Primary spontaneous pneumothorax', 'Secondary spontaneous pneumothorax']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Yasmin M Abo El Fadl, resident', 'role': 'CONTACT', 'email': 'yasmine_mahany_post@med.sohag.edu.eg', 'phone': '01152340826'}, {'name': 'Mona T hussein, professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident-chest department sohag university hospital', 'investigatorFullName': 'Yassmin Mehana Aboelfadel', 'investigatorAffiliation': 'Sohag University'}}}}