Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-04 @ 10:19 AM
Study NCT ID:
NCT06983366
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D011030', 'term': 'Pneumothorax'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discriminative performance of LSI (total score, 0-36) between disease groups', 'timeFrame': 'At Baseline', 'description': 'The primary outcome is establishing a pattern of LSI among the seven studied groups'}], 'secondaryOutcomes': [{'measure': 'Correlation of LSI with clinical severity indices', 'timeFrame': 'At Baseline', 'description': 'Correlation of LSI with clinical severity indices (PaO₂/FiO₂ ratio, FVC %, mMRC, 6MWT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD', 'ILD', 'Bronchiectasis', 'Pneumothorax', 'Pneumonia', 'Pleural Effusion Disorder', 'Pulmonary Oedema']}, 'descriptionModule': {'briefSummary': 'This upcoming case-control study aims to confirm the Lung Sliding Index (LSI), a new ultrasound score that measures how well the pleura moves, in various lung diseases. The study will check how well the LSI can tell apart different lung diseases (like pneumothorax, interstitial lung disease, COPD, pneumonia, and pulmonary edema), how it relates to signs of disease severity, and how consistent the results are between different operators who have received the same training. Secondary objectives include assessing patient and operator satisfaction and feasibility using validated Likert scales.', 'detailedDescription': "* The study will enroll adults with various pulmonary pathologies and healthy controls. Lung ultrasound will be performed on all subjects using a standardized 12-zone protocol; each zone will be scored for pleural sliding using the LSI (0-3 per zone; total 0-36). Operator training and calibration will precede enrollment to ensure scoring consistency.\n* A subset of patients will undergo repeat assessments to evaluate intra- and interobserver reliability, using independent, blinded raters.\n* For correlation with LSI, we will collect clinical data, including spirometry, blood gases, symptom scores, and 6-minute walk tests. Diagnostic utility will be evaluated using ROC curves. Satisfaction and feasibility will be assessed via Likert questionnaires, with validation analyses (internal consistency, test-retest reliability).\n* All data will be de-identified and securely stored. Written informed consent will be obtained from all participants.\n* The study groups will include:\n\n 1- Pneumothorax 2. Interstitial lung disease (ILD/IPF) 3. COPD/emphysema 4. Bronchiectasis 5. Community-acquired pneumonia 6. Pulmonary edema 7- Pleural effusion 8. Healthy controls\n* Data Collection Methods:\n* Standardized data entry forms for clinical, imaging, and outcome data.\n* Centralized digital storage with access limited to study personnel.\n\nStatistical Methods:\n\n\\- Descriptive statistics for baseline data ANOVA or Kruskal-Wallis for group comparisons; post hoc testing as appropriate ROC analysis for diagnostic cut-offs Pearson/Spearman correlation for clinical associations Intraclass correlation coefficients (ICC) for reliability Cronbach's alpha for Likert scale validation Multivariable regression for confounder adjustment"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (\\>18 years) with:\n\n* Pneumothorax\n* Interstitial lung disease (ILD/IPF)\n* COPD/emphysema\n* Bronchiectasis\n* Community-acquired pneumonia\n* Pulmonary edema\n* Pleural effusion\n* Healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older.\n* Diagnosed with one of the specified pulmonary diseases, or a healthy control\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to tolerate or undergo a lung ultrasound\n* Extensive chest wall pathology precluding assessment\n* Unscorable \\>2 zones per protocol\n* Withdrawal of consent\n* Mechanically-ventilated patients'}, 'identificationModule': {'nctId': 'NCT06983366', 'briefTitle': 'Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Validation and Clinical Utility of the Lung Sliding Index (LSI) for Differentiating Pulmonary Diseases: A Prospective Case-Control Study', 'orgStudyIdInfo': {'id': 'IRBAU3211-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD', 'description': 'Chronic obstructive pulmonary disease patients will be further classified as mild, moderate, severe, and very severe according to GOLD classification.', 'interventionNames': ['Diagnostic Test: Lung Ultrasound']}, {'label': 'Pneumothorax', 'description': 'Patients with Pneumothorax', 'interventionNames': ['Diagnostic Test: Lung Ultrasound']}, {'label': 'CAP', 'description': 'Community-acquired pneumonia will be classified using the CURB-65 score into mild, moderate, and severe.', 'interventionNames': ['Diagnostic Test: Lung Ultrasound']}, {'label': 'ILDs', 'description': 'Interstitial lung diseases will be further classified using FVC% classes, categorized as mild, moderate, and severe.', 'interventionNames': ['Diagnostic Test: Lung Ultrasound']}, {'label': 'Bronchiectasis', 'description': 'patients with non-cystic fibrosis bronchiectasis', 'interventionNames': ['Diagnostic Test: Lung Ultrasound']}, {'label': 'Pleural Effusion', 'description': 'Patients with pleural effusion', 'interventionNames': ['Diagnostic Test: Lung Ultrasound']}, {'label': 'Pulmonary Oedema', 'description': 'Patient with any degree of Pulmonary oedema', 'interventionNames': ['Diagnostic Test: Lung Ultrasound']}, {'label': 'Control', 'description': 'Healthy control subjects for comparison', 'interventionNames': ['Diagnostic Test: Lung Ultrasound']}], 'interventions': [{'name': 'Lung Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'All enrolled patient will be subjected to Lung Ultrasound examination LUS', 'armGroupLabels': ['Bronchiectasis', 'CAP', 'COPD', 'Control', 'ILDs', 'Pleural Effusion', 'Pneumothorax', 'Pulmonary Oedema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmad M. Shaddad, MD', 'role': 'CONTACT', 'email': 'Shaddad_ahmad@aun.edu.eg', 'phone': '+201111171939'}, {'name': 'Ahmad M. Shaddad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aliae A Hussein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maiada K Haahem, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assiut University- Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ahmad M. Shaddad, MD', 'role': 'CONTACT', 'email': 'shaddad_ahmad@yahoo.com', 'phone': '+201111171930'}], 'overallOfficials': [{'name': 'Ahmad M. Shaddad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}, {'name': 'Aliae A. Hussien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'the decision regarding sharing individual participant data is under review and will be updated when determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aliae AR Mohamed Hussein [ahussein', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of pulmonary medicine - faculty of medicine - Assuit University', 'investigatorFullName': 'Ahmad Shaddad', 'investigatorAffiliation': 'Assiut University'}}}}