Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT05727202
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project STARFISH - PRJ0002679
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The study population will be composed of participants suspected of a respiratory tract infection from SARS-COV-2, Influenza A/B, or RSV. For this study, 1 nasopharyngeal swab and 1 nasal swab will be collected from each participant recruited prospectively from at least three (3) collection sites located in different geographical regions in the US.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1909}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint', 'timeFrame': 'Between February 2023 and April 2024', 'description': 'The primary endpoint of this clinical performance study is to meet the minimum sample positivity requirements for nasopharyngeal samples as defined by relevant regulatory guidance.'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint', 'timeFrame': 'Between February 2023 and April 2024', 'description': 'The secondary endpoint of this study is to complete the clinical performance evaluation of the Starfish Test compared with that of a predicate device using Anterior nasal specimens and meet the minimum PPA and NPA requirements and acceptance criteria for each viral target as summarized in the protocol.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['SARS-CoV-2 Infection', 'Influenza A', 'Influenza Type B', 'RSV Infection']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor.', 'detailedDescription': 'The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (referred to below as "Starfish Test") aims to develop a multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).\n\nThe purpose of this performance study is to evaluate the clinical performance of the Starfish Test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria. This Clinical Performance Study Protocol (CPS Protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510(k) study requirements in the US.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be composed of participants suspected of respiratory tract infection from SARS-COV-2, Influenza A/B, or RSV. After a subject is determined eligible for study participation (met inclusion criteria and did not meet exclusion criteria) and has completed the institutional review board (IRB)-approved informed consent form process (or assent, as age appropriate), the subject is enrolled into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study.\n\n * Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection.\n * All-comers phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days.\n * Enrichment phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days, and with a standard of care positive PCR test result within three (3) days.\n\nExclusion Criteria:\n\n* Participants meeting the following criterion will be excluded from the study:\n\n * Suspected to have respiratory tract infection for greater than seven (7) days.\n * Patients not suspected of having a respiratory tract infection.'}, 'identificationModule': {'nctId': 'NCT05727202', 'acronym': 'STARFISH', 'briefTitle': 'Project STARFISH - PRJ0002679', 'organization': {'class': 'INDUSTRY', 'fullName': 'Thermo Fisher Scientific, Inc'}, 'officialTitle': 'IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679', 'orgStudyIdInfo': {'id': 'PCP0127284'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV-2 infection', 'description': '50 positive samples 500 negative samples', 'interventionNames': ['Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel']}, {'label': 'Influenza A infection', 'description': '50 positive samples 500 negative samples', 'interventionNames': ['Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel']}, {'label': 'Influenza B infection', 'description': '30 positive samples 500 negative samples', 'interventionNames': ['Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel']}, {'label': 'RSV infection', 'description': '30 positive samples 500 negative samples', 'interventionNames': ['Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel']}], 'interventions': [{'name': 'The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel', 'type': 'DIAGNOSTIC_TEST', 'description': 'A multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).', 'armGroupLabels': ['Influenza A infection', 'Influenza B infection', 'RSV infection', 'SARS-CoV-2 infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care Research", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32055', 'city': 'Lake City', 'state': 'Florida', 'country': 'United States', 'facility': 'Multi-Specialty Research Associates', 'geoPoint': {'lat': 30.18968, 'lon': -82.63929}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'D&H National Research Centers', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46037', 'city': 'Fishers', 'state': 'Indiana', 'country': 'United States', 'facility': 'Quantigen', 'geoPoint': {'lat': 39.95559, 'lon': -86.01387}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'KUR Research at Columbia Medical Practice', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '48127', 'city': 'Dearborn Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Vida Clinical Studies', 'geoPoint': {'lat': 42.33698, 'lon': -83.27326}}, {'zip': '64110', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'MRI Global', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Center of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07642', 'city': 'Hillsdale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'KUR Research at AFC Urgent Care', 'geoPoint': {'lat': 41.0026, 'lon': -74.04042}}, {'zip': '07652', 'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'KUR Research at AFC Urgent Care', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'zip': '27537', 'city': 'Henderson', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mako Medical Laboratories', 'geoPoint': {'lat': 36.32959, 'lon': -78.39916}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Progressive Medicine of the Triad', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'ClinSearch', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Helios Clinical Research', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '76248', 'city': 'Keller', 'state': 'Texas', 'country': 'United States', 'facility': 'Helios Clinical Research', 'geoPoint': {'lat': 32.93457, 'lon': -97.25168}}, {'zip': '84096', 'city': 'Riverton', 'state': 'Utah', 'country': 'United States', 'facility': 'Granger Medical Clinic', 'geoPoint': {'lat': 40.52189, 'lon': -111.9391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thermo Fisher Scientific, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NAMSA', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}