Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 2:24 PM
Study NCT ID:
NCT03988192
Status:
TERMINATED
Last Update Posted:
2022-01-27
First Post:
2018-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Evolution of the treatment procedures so that their is no more benefits for patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2019-06-14', 'lastUpdatePostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Profiles of Volatil Organic Compound (VOC) in exhaled air', 'timeFrame': '1 day', 'description': 'Comparison of variation of Volatil Organic Compound (VOC) profiles in exhaled air of patients before and during immunotherapy'}, {'measure': 'Variation of Volatil Organic Compound (VOC) in exhaled air', 'timeFrame': 'change from baseline profiles at week 9, week 18 and week 27 post-baseline', 'description': 'Correlation of variation with response to immunotherapy at week 9, 18 and 27 (according to RECIST criteria)'}], 'secondaryOutcomes': [{'measure': 'Profiles of Volatil Organic Compound (VOC) in sweat', 'timeFrame': '1 day', 'description': 'Comparison of variation of Volatil Organic Compound (VOC) profiles in sweat of patients before and during immunotherapy'}, {'measure': 'Variation of Volatil Organic Compound (VOC) in sweat', 'timeFrame': 'change from baseline profiles at week 9, week 18 and week 27 post-baseline', 'description': 'Correlation of variation with response to immunotherapy at week 9, 18 and 27 (according to RECIST criteria)'}, {'measure': 'Volatil Organic Compound (VOC) profile and radiological response', 'timeFrame': 'change from baseline profiles at week 9, week 18 and week 27 post-baseline', 'description': 'Correlation between Volatil Organic Compound (VOC) profile before treatment and radiological response at 9, 18 and 27 weeks (defined by RECIST criteria)'}, {'measure': 'Volatil Organic Compound (VOC) profile and drug toxicity', 'timeFrame': 'change from baseline profiles at week 9, week 18 and week 27 post-baseline', 'description': 'Correlation between variation of Volatil Organic Compound (VOC) profiles and apparition of drug toxicity at 9, 18 and 27 weeks'}, {'measure': 'Comparison of performance from Volatil Organic Compound (VOC) from exhaled air versus sweat', 'timeFrame': '1 day', 'description': 'Comparison of performance of Volatil Organic Compound (VOC) from exhaled air versus Volatil Organic Compound (VOC) from sweat'}, {'measure': 'Comparison of performance of mass spectrometry versus electronic noses', 'timeFrame': '1 day', 'description': 'Comparison of performance of Volatil Organic Compound (VOC) from mass spectrometry versus Volatil Organic Compound (VOC) from electronic noses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer, Non-small Cell']}, 'descriptionModule': {'briefSummary': 'The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The volatolomic analysis can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.\n\nImmunotherapy is a new therapeutic approach used in non small cell lung cancer in a late stage.\n\nVOC analysis could allow to identify biomarkers of early response to immunotherapy. The study of VOC could help in the optimisation of immunotherapy prescription in lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient aged \\> 18 years old\n* patient with metastatic non-small cell lung cancer with marketing authorisation criteria for immunotherapy\n* preserved overall condition (Performans Status 1)\n* signed informed consent\n* patient with healthcare insurance\n\nNon Inclusion Criteria:\n\n* patient with oxygen therapy or invasive ventilation\n* patient unable to perform a slow vital capacity\n* systemic corticosteroid therapy more than 10 mg per day of prednisone equivalent\n* previous treatment with immunotherapy\n* dermatological therapy interfering with sweat collection (psoriasis, irritant dermatitis, for instance)\n* Patient deprived of liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT03988192', 'acronym': 'Immuno-VOC', 'briefTitle': 'Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Volatile Organic Compounds in Exhaled Air and Sweat of Patients Treated by Immunotherapy for Lung Cancer: Research on Biomarkers for Early Therapeutic Response', 'orgStudyIdInfo': {'id': '2018042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VOC analysis', 'description': 'VOC analysis in exhaled air and sweat in patients treated by immunotherapy for lung cancer.', 'interventionNames': ['Device: VOC analysis']}], 'interventions': [{'name': 'VOC analysis', 'type': 'DEVICE', 'description': 'VOC analysis in exhaled air with e-noses and mass spectrometry.', 'armGroupLabels': ['VOC analysis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Philippe Devillier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pneumology department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}