Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-31 @ 5:38 AM
Study NCT ID:
NCT05286203
Status:
RECRUITING
Last Update Posted:
2022-07-07
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-03', 'mcpReleaseN': 3, 'releaseDate': '2025-09-16'}, {'resetDate': '2025-10-31', 'mcpReleaseN': 4, 'releaseDate': '2025-10-16'}, {'resetDate': '2025-11-19', 'mcpReleaseN': 5, 'releaseDate': '2025-11-05'}], 'estimatedResultsFirstSubmitDate': '2025-09-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-05', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-03-08', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement', 'timeFrame': '4-week after randomization', 'description': 'Dichotomous variable (Y/N) as assessed by a masked evaluator'}, {'measure': 'Appropriate therapy', 'timeFrame': '4-week after randomization', 'description': 'Dichotomous variable (Y/N) as determined by an independent expert panel'}], 'secondaryOutcomes': [{'measure': 'Provider certainty of belief', 'timeFrame': '4-week after randomization', 'description': 'Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%)'}, {'measure': 'Patient quality of life', 'timeFrame': '4-week after randomization', 'description': 'As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)'}, {'measure': 'Infection status', 'timeFrame': '4-week after randomization', 'description': 'Estimated through latent class analysis that compares MDS with traditional tests for presumed ocular infections. Sensitivity and specificity will be reported as percentage (%)'}, {'measure': 'Provider quality of care', 'timeFrame': '4-week after randomization', 'description': 'As measured by the World Health Organization Quality of Life Abbreviated Questionnaire (min = 0, max = 100; higher means better quality of life).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Uveitis', 'Metagenomic deep sequencing', 'Intraocular infection', 'MDS'], 'conditions': ['Uveitis', 'Infectious Disease']}, 'referencesModule': {'references': [{'pmid': '40653257', 'type': 'DERIVED', 'citation': 'Shantha JG, Moussa K, Laovirojjanakul W, Yeh S, Tsui E, Chen JL, Vitale AT, Shakoor A, Larochelle M, Niemeyer K, Mentreddy A, Livnat I, Safo M, Ao W, Choo C, Yan D, Zhong L, Chen C, Da Silva K, Reddy AK, Lee J, Sura A, Crowell EL, Qian Y, Sharon Y, Hinterwirth A, Porco T, Arnold BF, Gonzales J, Acharya NR, Lietman TM, Doan T; OPTICS Study Group. The Effect of Metagenomic Sequencing on Patient Clinical Outcomes for Intraocular Infections: A Multicenter Randomized Controlled Trial. Am J Ophthalmol. 2025 Nov;279:100-109. doi: 10.1016/j.ajo.2025.07.003. Epub 2025 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (MDS) versus standard of care testing for improvement of outcomes for intraocular infections. Patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive MDS testing results or not to receive MDS testing results. All patients will receive standard-of-care testing to guide management. Enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. The proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. Patient quality of life, MDS performance, and the provider certainly of belief will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis\n* Presumed post-operative endophthalmitis\n* Unilateral or bilateral\n* 18 years and older\n\nExclusion Criteria:\n\n* Insufficient specimen for MDS\n* Age \\< 18 years of age\n* Pregnancy\n* Unable to consent'}, 'identificationModule': {'nctId': 'NCT05286203', 'acronym': 'OPTICS', 'briefTitle': 'Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing', 'orgStudyIdInfo': {'id': 'P0555674'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.', 'interventionNames': ['Diagnostic Test: Standard of Care (SOC)']}, {'type': 'EXPERIMENTAL', 'label': 'MDS', 'description': 'Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.', 'interventionNames': ['Device: Metagenomic Deep Sequencing (MDS)']}], 'interventions': [{'name': 'Metagenomic Deep Sequencing (MDS)', 'type': 'DEVICE', 'description': 'MDS is an RNA-seq based testing of ocular fluid or tissue to identify potential infectious pathogens including bacteria, fungi, parasites, and DNA and RNA viruses.', 'armGroupLabels': ['MDS']}, {'name': 'Standard of Care (SOC)', 'type': 'DIAGNOSTIC_TEST', 'description': 'SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Shantha, MD, MAS', 'role': 'CONTACT', 'email': 'Jessica.Shantha@ucsf.edu'}, {'name': 'Thuy Doan, MD, PhD', 'role': 'CONTACT', 'phone': '415-476-6939'}], 'facility': 'University of California San Francisco (UCSF)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Jessica Shantha, MD', 'role': 'CONTACT', 'email': 'Jessica.shantha@ucsf.edu', 'phone': '(415) 476-1442'}, {'name': 'Thuy Doan, MD, PhD', 'role': 'CONTACT', 'phone': '415-476-6939'}], 'overallOfficials': [{'name': 'Thuy Doan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nebraska', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}