Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02512757
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2015-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Subjects will consent to archiving and future analysis of their blood samples for up to twenty (20) years.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2015-07-27', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic performance of AminoIndex™ to discriminate lung cancer patients from high-risk subjects.', 'timeFrame': '6 months', 'description': 'To evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk for developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy and histopathology.'}], 'secondaryOutcomes': [{'measure': 'The capability of AminoIndex™ to distinguish malignant lung cancer from benign lung nodules.', 'timeFrame': '6 months'}, {'measure': 'Gathering residual patient samples that will be used for discovery research.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neoplasms, Lung', 'Pulmonary Neoplasms', 'Pulmonary Cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center study to evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk for developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy and histopathology.', 'detailedDescription': 'This is a prospective, multi-center study to evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk for developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy and histopathology.\n\nThe study will enroll patients into one of three arms:\n\n1. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and diagnosed with primary lung cancer who have not yet initiated treatment of any kind for their lung cancer;\n2. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and determined to not be cancerous OR that have demonstrated no nodule growth for \\> 2 years by repeat CT imaging; and\n3. patients at high-risk for lung cancer (per NLST guidelines) with no evidence or history of lung cancer (negative LDCT/CT/X-ray).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study will enroll sufficient subjects to yield a minimum of 60 subjects in Study Group 1, 30 subjects in Study Group 2 and 60 subjects in Study Group 3 - a total of 150 evaluable study subjects who meet all inclusion and exclusion criteria. Eligible subjects will be men and women age ≥ 18 years for Group 1 and 2 and 55 - 79 years inclusive for Group 3. Group 3 study subjects must also meet NLST guidelines of being at high risk for lung cancer: greater than or equal to a 30 pack year smoking history (equivalent of 1 pack per day for 30 or more years) and a current smoker or quit less than 15 years ago.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nAll Groups:\n\n* Able to read, understand and sign informed consent to participate in study.\n* Willing and able to provide written informed consent.\n* Willing and able to meet all study requirements and undergo venipuncture to provide a fasting blood sample.\n\nGroup 1:\n\n* Men or women age 18 years or older;\n* Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung, nodule or mass.\n* Diagnosis of lung cancer based upon histopathology performed on lung nodule, lesion or mass tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained.\n\nGroup 2:\n\n* Men or women age 18 years or older;\n* Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung nodule, lesion or mass;\n* Definitive diagnosis of benign (non-cancerous) lung nodule based upon one of the following:\n\n * Histopathology performed on lung nodule tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained;\n * No nodule growth for \\> 2 years by repeat CT imaging, the most recent being performed within the 60 days prior to signing informed consent.\n\nGroup 3:\n\n* Men or women age 55-79 years inclusive;\n* Current smoker or quit \\< 15 years ago with a \\> 30 pack-year smoking history (equivalent of 1 pack per day for 30 or more years)\\*.\n* Have undergone low-dose computed tomography (LDCT) or standard computed tomography (CT) or X-ray testing to screen for lung cancer with no nodules suspicious for lung cancer within 1 year prior to signing informed consent.\n\n\' \\* \' One pack year is calculated as follows: 20 cigarettes = 1 pack. One "pack year" is the equivalent of smoking:\n\n* 20 cigarettes (one pack) per day for one year; or\n* 40 cigarettes (two packs) per day for 6 months; or\n* 60 cigarettes (three packs) per day for 3 months\n\nExclusion Criteria\n\n* Inability to fast for 8 hours prior to the blood sample collection.\n* Known to be positive for HIV and/or, HBV and/or HCV.\n* Pregnancy.\n* Breastfeeding.\n* Currently undergoing dialysis.\n* Congenital metabolic disease.\n* Currently receiving investigational treatments of any type.\n* History of receiving any drug therapy or surgery for the treatment of lung cancer.\n* Diagnosis of cancer within past 5 years and/or currently undergoing treatment for any cancer.\n* Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated.'}, 'identificationModule': {'nctId': 'NCT02512757', 'briefTitle': 'A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovis LLC'}, 'officialTitle': 'The AminoIndex™ Study - A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology', 'orgStudyIdInfo': {'id': 'Ajinomoto 2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and diagnosed with primary lung cancer who have not yet initiated treatment of any kind for their lung cancer will contribute a fasting blood sample.'}, {'label': 'Group 2', 'description': 'Patients whose most recent screening imaging is within 60 days who have lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and determined to not be cancerous OR that have demonstrated no nodule growth for \\>2 years by repeat CT imaging will contribute a fasting blood sample.'}, {'label': 'Group 3', 'description': 'Patients who have undergone low-dose computed tomography (LDCT) or standard computed tomography (CT) or X-ray testing to screen for lung cancer with no nodules suspicious for lung cancer within 1 year prior to signing informed consent will contribute a fasting blood sample.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Lung Asthma and Sleep Specialists P.A.', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pulmonary and Critical Care Associates of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center (VICC)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Gregg S. Britt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Innovis LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovis LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ajinomoto Co., Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}