Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-06 @ 6:49 AM
Study NCT ID:
NCT04827667
Status:
UNKNOWN
Last Update Posted:
2021-04-06
First Post:
2021-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of PD1-lymphocytes in Bronchoalveolar Lavage of Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-04', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess and compare PD1-lmyphocytes in bronchoalveolar lavage in patients with malignant and benign lung diseases to evluate their impact in lung cancer patients', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to assess PD1-lymphocytes in bronchoalveolar lavage in patients with lung cancer, ILD and asthma.', 'detailedDescription': 'In this trial, 20 patients with lung cancer, 10 patients with asthma and 10 patients with interstitial lung disease who have to undergo bronchocospy for medical reasons are enrolled. In each patient, bronchoalveolar lavage is performed to assess PD1-lymphocytes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected or proven lung cancer, asthma or instertitial lung disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* patients with lung cancer, asthma or ILD and indication for bronchoscopy for medical reasons\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* acute excacerbation in patients with asthma or ILD\n* endoluminal tumor growth or penumonia in patients with lung cancer'}, 'identificationModule': {'nctId': 'NCT04827667', 'briefTitle': 'Impact of PD1-lymphocytes in Bronchoalveolar Lavage of Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Vienna'}, 'officialTitle': 'Impact of PD1-lymphocytes in Bronchoalveolar Lavage of Patients With Lung Cancer', 'orgStudyIdInfo': {'id': 'Version 1 20.04.2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with lung cancer', 'description': 'In lung cancer patients with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.', 'interventionNames': ['Diagnostic Test: bronchoalveolar lavage']}, {'label': 'Patients wiht interstitial lung disease', 'description': 'In patients with interstitial lung disease with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.', 'interventionNames': ['Diagnostic Test: bronchoalveolar lavage']}, {'label': 'Patients with asthma', 'description': 'In patients with asthma with indication for bronchoscopy, bronchoalveolar lavage is performed to assess PD1-lymphocytes.', 'interventionNames': ['Diagnostic Test: bronchoalveolar lavage']}], 'interventions': [{'name': 'bronchoalveolar lavage', 'type': 'DIAGNOSTIC_TEST', 'description': 'Bronchoalveolar lavage is performed by instillation and suction of saline in the middle lobe during bronchoscopy. Cytological examination and flow cytometry will be performed to assess PD-1lymphoctes.', 'armGroupLabels': ['Patients wiht interstitial lung disease', 'Patients with asthma', 'Patients with lung cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Daniela Gompelmann', 'role': 'CONTACT', 'email': 'daniela.gompelmann@meduniwien.ac.at', 'phone': '0043 1 40400 47730'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Daniela Gompelmann', 'role': 'CONTACT', 'email': 'daniela.gompelmann@meduniwien.ac.at', 'phone': '0043 1 40400 47730'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Daniela Gompelmann', 'investigatorAffiliation': 'University of Vienna'}}}}