Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-02 @ 2:03 AM
Study NCT ID:
NCT01840150
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2013-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer
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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2013-04-23', 'studyFirstSubmitQcDate': '2013-04-23', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful evaluation of gas samples taken from lung cancer patients', 'timeFrame': 'Up to 3 years'}, {'measure': 'Percent of patients that become nanoscale artificial nose negative within 3 years post-surgery', 'timeFrame': 'Up to 3 years', 'description': 'We will test the null hypothesis that at most 30% of patients will become nanoscale artificial nose negative within 3 years post- surgery. The alternative will be that this fraction will be at least 50%. If at least 15/35 patients become nanoscale artificial nose negative within 3 years post treatment follow up we will reject the null. The test has 84.5% power and 7.31% type I error.'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients who become nanoscale artificial nose negative within 3 years and recur within that time frame that will become nanoscale artificial nose positive before recurrence', 'timeFrame': 'Up to 3 years', 'description': 'We will test the hypothesis that at most 25% of patients who become nanoscale artificial nose negative within 3 years and recur within that time frame will become nanoscale artificial nose positive before recurrence. The alternative is that at least 50% of such patients will become nanoscale artificial nose positive before recurrence.'}, {'measure': 'Time to become nanoscale artificial nose negative post treatment', 'timeFrame': 'Up to 3 years', 'description': 'This will be done using the method of Kaplan and Meier.'}, {'measure': 'Lead time between the transition from nanoscale artificial nose negativity to positivity and clinical recurrence', 'timeFrame': 'Up to 3 years', 'description': 'We will restrict this estimate to data from patients who experience a transition and will use the method of Kaplan and Meier. We will tabulate frequencies of patients who recur with or without such a transition as well as those for patients who never become nanoscale artificial nose negative.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stage IA Non-small Cell Lung Cancer', 'Stage IB Non-small Cell Lung Cancer', 'Stage IIA Non-small Cell Lung Cancer', 'Stage IIB Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies nanoscale artificial nose (NA-NOSE) in monitoring response and detecting recurrence after surgery or radiation therapy in patients with stage I or stage II non-small cell lung cancer (NSCLC). Using the NA-NOSE breath test may be an effective way to monitor response and detect recurrence of NSCLC after surgery or radiation therapy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine if a suitable fraction of patients become NA-NOSE negative within three years post treatment. We will test the hypothesis that this fraction is at most 30% versus the alternative that it is at least 50%.\n\nSECONDARY OBJECTIVES:\n\nI. Determine if patients who become NA-NOSE negative post treatment then become NA-NOSE positive prior to clinical recurrence.\n\nII. Estimate the time post treatment needed to become NA-NOSE negative. III. Estimate the lead time gained between a negative to positive NA-NOSE transition and clinical recurrence.\n\nOUTLINE:\n\nPatients undergo breath sample collection for the NA-NOSE breath test at baseline (2 pre-treatment samples), and post treatment samples at regularly scheduled follow up visits, for 2 years in the absence of disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must either have histologic or pathologically confirmed non-small cell lung cancer (NSCLC) or suspicious nodules/lesions which are going to be surgically resected before they are pathologically confirmed\n* Patients must have stage I or II disease based on the parameters for staging NSCLC found in the American Joint Committee on Cancer (AJCC) cancer staging handbook seventh edition\n* Patients must be deemed to be eligible candidates for either surgery or stereotactic radiation\n* Stereotactic radiation treatment of stage I disease or adjuvant chemotherapy is allowed at the discretion of treating physician for the participating subject\n* Patients who will have surgical resections must consent to the use of post-surgery tumor samples for correlative molecular studies\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Ability to travel to appointments and willingness to participate in this study\n* Ability to understand and willingness to sign a consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form\n\nExclusion Criteria:\n\n* Patients who have had a prior lung cancer within the last five years from the current diagnosis\n* Patients having a prior malignancy within the past 3 years other than resected of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapy\n* Patients with any prior systemic therapy for the current diagnosis of lung cancer\n* Patients with a diagnosis of advanced stage disease (stage III or IV)\n* Patients who are unable to comply with study and/or follow up procedures\n* Patients who have uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements\n* Patients who are pregnant or are breast feeding'}, 'identificationModule': {'nctId': 'NCT01840150', 'briefTitle': 'Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fox Chase Cancer Center'}, 'officialTitle': 'A Single-center Study to Evaluate the Feasibility of a Novel NA-NOSE for Monitoring Response to and Detecting Recurrence After Surgery or Radiation in Early Stage Lung Cancer', 'orgStudyIdInfo': {'id': 'TH-040'}, 'secondaryIdInfos': [{'id': 'NCI-2011-03308', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'IRB#11-052'}, {'id': 'TH-040', 'type': 'OTHER', 'domain': 'Fox Chase Cancer Center'}, {'id': 'P30CA006927', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006927', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (NA-NOSE breath test)', 'description': 'Patients undergo breath sample collection for the NA-NOSE breath test at baseline (2 pre-treatment samples), and post-treatment samples at regularly scheduled follow up visits, for 2 years in the absence of disease progression.', 'interventionNames': ['Procedure: breath test', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'breath test', 'type': 'PROCEDURE', 'description': 'Undergo NA-NOSE breath test', 'armGroupLabels': ['Treatment (NA-NOSE breath test)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (NA-NOSE breath test)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19111-2497', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Hossein Borghaei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}