Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-28 @ 11:55 PM
Study NCT ID:
NCT04654104
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2020-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Checkpoints in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2020-11-20', 'studyFirstSubmitQcDate': '2020-11-27', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PD-L1 in bronchoalveolar lavage fluid', 'timeFrame': '1 month', 'description': 'to evaluate the expression of PD-L1'}, {'measure': 'CTLA-4 in bronchoalveolar lavage fluid', 'timeFrame': '1 month', 'description': 'to evaluate the expression of CTLA-4'}, {'measure': 'mucin-domain containing-3 (TIM-3)', 'timeFrame': '1 month', 'description': 'to evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid'}, {'measure': 'PD-1 in bronchoalveolar lavage fluid', 'timeFrame': '1 month', 'description': 'to evaluate the expression of PD-1'}], 'secondaryOutcomes': [{'measure': 'check point and smoke', 'timeFrame': '1 month', 'description': 'to evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['systemic diseases'], 'conditions': ['Lung Cancer', 'Severe ARDS', 'Asthma', 'Copd']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung cancer, will be evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.\n\nAlthough there are many epidemiological studies highlighting the interconnections between COPD and lung cancer and the influence of cigarette smoke, the molecular bases of this association are less well defined. Initially they were thought to be driven just by innate inflammation, however, recent studies have also demonstrated the influence of the adaptive immune system. Despite this, the role of immune checkpoints in chronic lung inflammatory diseases such as COPD is less well understood. COPD is currently the 4th leading cause of death worldwide but is assessed to be the 3rd by the end of 2020 resulting in an economic and social burden that is in continuous progression.', 'detailedDescription': 'The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung cancer, will be evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.\n\nAlthough there are many epidemiological studies highlighting the interconnections between COPD and lung cancer and the influence of cigarette smoke, the molecular bases of this association are less well defined. Initially they were thought to be driven just by innate inflammation, however, recent studies have also demonstrated the influence of the adaptive immune system. Despite this, the role of immune checkpoints in chronic lung inflammatory diseases such as COPD is less well understood. COPD is currently the 4th leading cause of death worldwide but is assessed to be the 3rd by the end of 2020 resulting in an economic and social burden that is in continuous progression.\n\nPatients will be recruited from from the outpatient clinics of the Pulmonary and Critical Care Medicine department of "Mauro Scarlato" Hospital in Scafati, Italy in collaboration with the Operational Unit of Clinical Pharmacology and Pharmacovigilance of Catanzaro University.\n\n171 patients will be divided according to the results of the anatomopathological examinations into four groups:\n\n* Healthy never smokers\n* Smokers with normal lung\n* Cancer\n* COPD (COPD group was divided in two subgroups: GOLD 1-2 group and GOLD 3-4 group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The levels of PD-1, PD-L1 and CTLA-4 will be evaluated by immunofluorescence and by RT-PCR on biopsy samples, which will be taken according to normal clinical practice. The checkpoint levels will be assessed before and after exposure after a medium of smoke also in the macrophages extracted from the BAL, which will be collected according to normal clinical practice, by RT-PCR.\n\nThe aforementioned experiments will be carried out at the Pharmacology Section of the Department of Experimental Medicine, University of Campania Luigi Vanvitelli, their cost will not be borne by the NHS but will be fully borne by the aforementioned University.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • over 18 years of age with suspected diagnosis of pulmonary neoplasia\n\n * signed the informed consent\n\nExclusion Criteria:\n\n* • infected diseases\n\n * interstitiopathy\n * asthma,\n * autoimmune diseases,\n * neoplasia other than inclusion criteria\n * subjects on glucocorticoid therapy\n * alcohol consumption (\\>3 alcoholic beverages daily)\n * substance abuse\n * inability to give written informed consent\n * those who will not sign the consent to the processing of personal data'}, 'identificationModule': {'nctId': 'NCT04654104', 'acronym': 'CP-COPD', 'briefTitle': 'Immune Checkpoints in COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Catanzaro'}, 'officialTitle': 'Predictive Role of Immune Checkpoints in COPD Evolution Towards Lung Cancer', 'orgStudyIdInfo': {'id': '361/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy never smokers', 'description': 'Clinical evaluation of immune check points expression. A prospective study', 'interventionNames': ['Other: check immune check points']}, {'label': 'Smokers with normal lung function', 'description': 'evaluation of immune check points expression', 'interventionNames': ['Other: check immune check points']}, {'label': 'Lung cancer', 'description': 'evaluation of immune check points expression', 'interventionNames': ['Other: check immune check points']}, {'label': 'COPD', 'description': 'evaluation of immune check points expression', 'interventionNames': ['Other: check immune check points']}], 'interventions': [{'name': 'check immune check points', 'type': 'OTHER', 'description': 'we will evaluate the expression of immune check points', 'armGroupLabels': ['COPD', 'Healthy never smokers', 'Lung cancer', 'Smokers with normal lung function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'state': 'CZ', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Gallelli, MD', 'role': 'CONTACT', 'email': 'gallelli@unicz.it', 'phone': '0961712322', 'phoneExt': '+39'}], 'facility': 'Luca Gallelli', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '88100', 'city': 'Catanzaro', 'state': 'Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Gallelli, MD', 'role': 'CONTACT', 'email': 'gallelli@unicz.it', 'phone': '+390961712537'}], 'facility': 'AO Materdomini', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'centralContacts': [{'name': 'Luca Gallelli, MD', 'role': 'CONTACT', 'email': 'gallelli@unicz.it', 'phone': '3339245656'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '12 months', 'ipdSharing': 'YES', 'description': 'publication of the results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catanzaro', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Sanitaria Provinciale Di Catanzaro', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliera Universitaria Mater Domini, Catanzaro', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Luca Gallelli', 'investigatorAffiliation': 'University of Catanzaro'}}}}