Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-29 @ 3:27 PM
Study NCT ID:
NCT04556435
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breath Analysis in Early Stage Lung Cancer Using Infrared Spectroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Change in the sponsor's business strategy (new focus on breast cancer)", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VOC spectral profile differences', 'timeFrame': '30 days after completion', 'description': 'VOC spectral profiles will be compared between cohorts to identify statistical differences.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Volatile Organic Compounds', 'Breath Analysis', 'Infrared Spectroscopy'], 'conditions': ['Lung Cancer', 'Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '30207593', 'type': 'BACKGROUND', 'citation': 'Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.'}, {'pmid': '30956412', 'type': 'BACKGROUND', 'citation': 'Henderson B, Khodabakhsh A, Metsala M, Ventrillard I, Schmidt FM, Romanini D, Ritchie GAD, Te Lintel Hekkert S, Briot R, Risby T, Marczin N, Harren FJM, Cristescu SM. Laser spectroscopy for breath analysis: towards clinical implementation. Appl Phys B. 2018;124(8):161. doi: 10.1007/s00340-018-7030-x. Epub 2018 Jul 28.'}], 'seeAlsoLinks': [{'url': 'https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer-facts-and-figures-2019.pdf', 'label': 'American Cancer Society. Cancer Facts \\& Figures 2019.'}, {'url': 'https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html', 'label': 'American Cancer Society. Non-Small Cell Lung Cancer Survival Rates (2016)'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to sample and analyze volatile organic compounds (VOCs) from lung cancer patients and individuals without lung cancer ("healthy" controls). The breath sample analysis will help investigators describe and identify profiles of VOCs found in the breath of patients with lung cancer when compared to normal breath profiles using infrared spectroscopy. This work will help validate early proof of concept results conducted with prototype technology and later stage NSCLC breath samples, and inform future breath testing analysis.', 'detailedDescription': 'Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will analyze breath samples from study participants with diagnosed lung adenocarcinoma not currently receiving curative treatment and matched control participants without lung cancer. Prospective participants will be pre-screened prior to being approached about the study. Those scheduled for upcoming appointments will undergo a chart review to determine whether they meet eligibility criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nLC Group:\n\n* ≥ 18 years;\n* Able to give informed consent;\n* Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);\n* Clinical evidence of lung cancer (metastatic or primary), inclusive of those receiving non-curative treatment, has not yet been treated or is not currently on treatment;\n* No history of or any other active cancer;\n* Able to provide a breath sample;\n\nControl Group:\n\n* ≥ 18 years;\n* Able to give informed consent;\n* Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);\n* No history of lung cancer or any other active cancer and is eligible for lung cancer screening;\n* Able to provide a breath sample;\n\nExclusion Criteria\n\n* Has received or is currently receiving curative treatment and may no longer have lung cancer;\n* Cannot give informed consent;'}, 'identificationModule': {'nctId': 'NCT04556435', 'briefTitle': 'Breath Analysis in Early Stage Lung Cancer Using Infrared Spectroscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Breathe BioMedical Inc'}, 'officialTitle': 'Analysis of Volatile Chemicals in the Breath of Lung Cancer Patients Using Infrared Spectroscopy', 'orgStudyIdInfo': {'id': '2019-5606'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LC Group', 'description': 'Participants will provide two breath samples by exhaling into the breath sampling apparatus and complete the Medical Questionnaire (medications, lifestyle, demographics, smoking history) and survey (lung health). Information related to LC diagnosis (histologic sub-type, tumor stage) will be collected.'}, {'label': 'Control Group', 'description': 'Participants will provide two breath samples by exhaling into the breath sampling apparatus and complete the Medical Questionnaire (medications, lifestyle, demographics, smoking history) and survey (lung health).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Mia Martinez', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Ali Mahtabifard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Breathe BioMedical Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}