Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-03-28 @ 9:44 PM
Study NCT ID:
NCT07051161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Interventional Endoscopy on Quality of Life in Patients With Acute Respiratory Distress Due to Tumor Compression or Obstruction of the Lower Respiratory Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020680', 'term': 'Bronchoscopes'}], 'ancestors': [{'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Saint George Score (quality of life)', 'timeFrame': 'At inclusion, and 7 days after therapeutic bronchoscopy', 'description': 'Difference between Saint-George score at inclusion and Day 7.\n\nThe scores for each dimension range from 0 to 100, with a score of 100 indicating excellent health.'}], 'secondaryOutcomes': [{'measure': 'Saint-George and SF-12 (12-Item Short-Form Health Survey) score', 'timeFrame': 'at inclusion and Day 30', 'description': 'Difference of these scores between inclusion and Day 30\n\nThe scores for each dimension of the Saint-George score range from 0 to 100, with a score of 100 indicating excellent health.\n\nThe SF-12 score ranges from 1 to 60, with a score of 60 indicating very poor quality of life.'}, {'measure': 'ECOG-performance Status', 'timeFrame': 'inclusion and Day 30', 'description': 'It ranges from 0 (fully active) to 5 (dead).'}, {'measure': 'Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen)', 'timeFrame': 'During the 30 first days from intervention'}, {'measure': 'hospitalization duration', 'timeFrame': 'During the 30 first days from intervention'}, {'measure': 'anti-tumoral treatment', 'timeFrame': 'During the 30 first days from intervention', 'description': 'initiation or continuation of anti-tumour treatment (radiotherapy, chemotherapy, immunotherapy, targeted therapy)'}, {'measure': 'survival', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Cancer', 'Bronchial Endoscopy', 'Therapeutic Bronchofiberscopy']}, 'referencesModule': {'references': [{'pmid': '38391185', 'type': 'BACKGROUND', 'citation': 'Roy P, Fournier C, Barnestein R, Wallyn F, Bourinet V, Briault A, Camuset J, Cellerin L, Crutu A, Dewolf M, Egenod T, Favrolt N, Heluain V, Lorut C, Mangiapan G, Schlossmasscher P, Toublanc B, Usturoi D, Legodec J, Vergnon JM, Pajiep Chapda MC, Dutau H, Guibert N. Outcomes of Therapeutic Bronchoscopy in Malignant Airway Obstruction Causing Acute Respiratory Failure. Ann Am Thorac Soc. 2024 May;21(5):833-837. doi: 10.1513/AnnalsATS.202311-943RL. No abstract available.'}, {'pmid': '40188807', 'type': 'BACKGROUND', 'citation': 'Roy P, Roy P, Amari L, Laroumagne S, Legodec J, Fournier C, Cellerin L, Lorut C, Gonin F, Vergnon JM, Egenod T, Favrolt N, Schlossmacher P, Bourinet V, Perrot L, Lachkar S, Camuset J, Briault A, Degot T, Gut-Gobert C, Mangiapan G, Jasnot JY, Briens E, Crutu A, Marceau A, Toublanc B, Dewolf M, Dutilh J, Germain N, Tronchetti J, Astoul P, Guibert N, Dutau H. Predictive Factors of Clinical Success of Therapeutic Bronchoscopy in Malignant Central Airway Obstruction: Results from the EpiGETIF Registry. Respiration. 2025;104(9):667-677. doi: 10.1159/000545568. Epub 2025 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'Bronchoscopic endoscopy has shown its effectiveness and reliability for the treatment (desobstruction or prothesis) of tumor-induced bronchial obstructions, particularly in the first few weeks. The presence of a lower airway prosthesis can lead to device obstruction requiring daily inhaled fluidification, bacterial colonization, migration of the prosthesis, or the appearance of obstructive or hemorrhagic granulomas.\n\nThe aim of this study is to evaluate the quality of life of patients after endobronchial treatment.\n\nIt is a prospective, descriptive, and multicentric (national) study. The main objective is to compare the total score on the Saint-George questionnaire at J7 of the interventional endoscopy compared to before the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n* \\>18 years old\n* tumoral tracheobronchial obstruction and/or compression\n* proven solid cancer or suspicion\n* Acute respiratory distress (at least one of the 5):\n\n * RR : ≥25/min\n * Sign of respiratory struggle\n * Sign of respiratory failure\n * Oxygen therapy ≥5L/min\n * Ventilatory support (NIV, OHD or IT) :\n* Indication for therapeutic interventional endoscopy\n* No guardianship or curatorship\n* Non-hematological tumor\n\nExclusion Criteria:\n\n* Minors\n* patients with neurological disabilities unable to understand and respond to the questionnaire\n* patients under guardianship or curatorship', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* tumoral tracheobronchial obstruction and/or compression\n* proven solid cancer or suspicion\n* Acute respiratory distress (at least one of the 5):\n\n * RR : ≥25/min\n * Sign of respiratory struggle\n * Sign of respiratory failure\n * Oxygen therapy ≥5L/min\n * Ventilatory support (NIV, OHD or IT) :\n* Indication for therapeutic interventional endoscopy\n* No guardianship or curatorship\n* Non-hematological tumor\n\nExclusion Criteria:\n\n* Minors\n* patients with neurological disabilities unable to understand and respond to the questionnaire\n* patients under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT07051161', 'acronym': 'ENDoRA', 'briefTitle': 'Impact of Interventional Endoscopy on Quality of Life in Patients With Acute Respiratory Distress Due to Tumor Compression or Obstruction of the Lower Respiratory Tract', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Impact of Interventional Endoscopy on Quality of Life in Patients With Acute Respiratory Distress Due to Tumor Compression or Obstruction of the Lower Respiratory Tract', 'orgStudyIdInfo': {'id': '38RC24.0408'}, 'secondaryIdInfos': [{'id': '2024-A02698-39', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'bronchoscope', 'type': 'PROCEDURE', 'otherNames': ['desobstruction of lower respiratory tract'], 'description': 'procedure performed by bronchoscopy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anne-Claire Toffart, MD-PhD', 'role': 'CONTACT', 'email': 'atoffart@chu-grenoble.fr', 'phone': '+33476766831'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}