Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-11 @ 10:29 PM
Study NCT ID:
NCT03116633
Status:
COMPLETED
Last Update Posted:
2019-05-16
First Post:
2017-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-15', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.', 'timeFrame': '12 months', 'description': 'The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis', 'timeFrame': '12 months', 'description': 'Detection of sensitivity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis'}, {'measure': 'Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis', 'timeFrame': '12 months', 'description': 'Detection of specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis'}, {'measure': 'Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved', 'timeFrame': '12 months', 'description': 'Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited (Quantity Not Sufficient) versus that observed where tumour biopsy is achieved.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'biopsy'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer', 'detailedDescription': 'The primary aim of this study is to investigate the concordance of Inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-squamous non-small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written, signed and dated informed consent\n* Male \\& female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.\n* Patients intended to initiate first-line treatment (Arms A and B)\n* Patients who plan to have or have had a recent tumor tissue biopsy taken as part of their standard of care (Arm A)\n* Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.\n\nExclusion Criteria:\n\n* Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy\n* Any history of metastatic cancer.\n* Previous malignancy in the last 2 years (except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix).\n* Patient with a severe acute or chronic medical or psychiatric condition or laboratory abnormality'}, 'identificationModule': {'nctId': 'NCT03116633', 'briefTitle': 'Concordance of Inivata Liquid Biopsy With Standard Tissue Biopsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inivata'}, 'officialTitle': 'An Observational Multicenter Study to Evaluate the Performance and Utility of Inivata Liquid Biopsy Analysis Compared With Tissue Biopsy Analysis for Detection of Genomic Alterations in Patients With Lung Cancer', 'orgStudyIdInfo': {'id': 'GRN-ALV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm A', 'description': '1st line setting-approx. 150 patients. collect tissue biopsy per standard of care \\& one blood draw (40ml)'}, {'label': 'Arm B', 'description': '1st line setting- approx. 100 patients one blood draw (40ml)'}, {'label': 'Arm C', 'description': 'Approx. 10 patients tissue collection optional 3 blood draws (40ml) over 5 days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72903', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Mercy Hospital Cancer Center/Clinical Research', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '64804', 'city': 'Joplin', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Cancer Center', 'geoPoint': {'lat': 37.08423, 'lon': -94.51328}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Clinic', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Mercy Clinic Oncology & Hematology', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Health Networks', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Gibbs Cancer Center & Research Institute', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inivata', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Guardian Research Network, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}