Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 4:13 PM
Study NCT ID:
NCT05602259
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of eosinophils in untreated non-small cell lung cancer patients', 'timeFrame': 'Baseline (pre-treatment)', 'description': 'Concentration of eosinophils will be used in various bodily materials as described above.'}], 'secondaryOutcomes': [{'measure': 'Prognostic and predictive value of eosinophils in non-small cell lung cancer patients', 'timeFrame': 'Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This prospective study will examine eosinophils in various biological materials to compare the detection in those materials and ascertain the prognostic and predictive role of eosinophils in untreated non-small cell lung cancer patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* o All stages of NSCLC\n\n * Stage III-IV NSCLC eligible for ICI treatment\n * 18 years or older; non pregnant women\n * in stage III-IV: no previous ICI and before ICI (mono- or combination therapy) initiation\n * Signed informed consent\n * Clinical, biological and radiological evaluation at the CHU de Liège for at least 6 months following treatment initiation\n\nExclusion Criteria:\n\n* Probable noncompliance with the follow-up requirements of the study (psychiatric condition, socio-economic factors)\n* Inclusion in a clinical study contraindicating the enrolment in the PROTEON study'}, 'identificationModule': {'nctId': 'NCT05602259', 'acronym': 'PROTEON', 'briefTitle': 'PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Liege'}, 'officialTitle': 'PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC) (PROTEON).', 'orgStudyIdInfo': {'id': '2022/258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eosinophil detection', 'description': 'Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.', 'interventionNames': ['Diagnostic Test: induced sputum', 'Diagnostic Test: lung biopsy', 'Diagnostic Test: bronchoalveolar lavage', 'Diagnostic Test: blood draw']}], 'interventions': [{'name': 'induced sputum', 'type': 'DIAGNOSTIC_TEST', 'description': 'After premedication with 400 μg inhaled salbutamol, sputum will be induced by inhalation of hypertonic (NaCl 3%) or isotonic (NaCl 0.9%) saline combined according to the FEV-1 value (\\> or ≤ than 65% predicted). Saline will be combined with additional salbutamol delivered by an ultrasonic nebulizer (Ultra-Neb 2000; Devilbiss, Somerset, PA, USA) with an output set at 0.9 ml/min. Each subject will inhale the aerosol for three consecutive periods of 5 min for a total of 15 min. For safety reasons, FEV-1 will be monitored throughout the induction and will be stopped if FEV-1 would fall by more than 20% from baseline.', 'armGroupLabels': ['Eosinophil detection']}, {'name': 'lung biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.', 'armGroupLabels': ['Eosinophil detection']}, {'name': 'bronchoalveolar lavage', 'type': 'DIAGNOSTIC_TEST', 'description': "When available, the remaining material from a patient's bronchoalveolar lavage will be collected.", 'armGroupLabels': ['Eosinophil detection']}, {'name': 'blood draw', 'type': 'DIAGNOSTIC_TEST', 'description': 'As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.', 'armGroupLabels': ['Eosinophil detection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Anne Sibille, MD', 'role': 'CONTACT', 'email': 'anne.sibille@chuliege.be', 'phone': '+3243237400'}, {'name': 'Aurore Cue Alvarez', 'role': 'CONTACT', 'email': 'aurore.cuealvarez@chuliege.be', 'phone': '+3243235539'}], 'facility': 'CHU de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Anne Sibille, MD', 'role': 'CONTACT', 'email': 'anne.sibille@chuliege.be', 'phone': '+3243237452'}, {'name': 'Aurore Cue Alvarez', 'role': 'CONTACT', 'email': 'aurore.cuealvarez@chuliege.be', 'phone': '+3243235539'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Anne Sibille', 'investigatorFullName': 'Anne Sibille', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Liege'}}}}