Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-24 @ 7:38 AM
Study NCT ID:
NCT04101604
Status:
UNKNOWN
Last Update Posted:
2019-09-27
First Post:
2019-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Common Eye Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D000092342', 'term': 'Polypoidal Choroidal Vasculopathy'}, {'id': 'D014607', 'term': 'Uveomeningoencephalitic Syndrome'}, {'id': 'D001528', 'term': 'Behcet Syndrome'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral blood mononuclear cell (PBMC) signatures', 'timeFrame': '1 year', 'description': 'PBMC signatures, derived from single cell sequencing and mass spectrometry, will be compared for the same patient before and after treatment, among patients of different symptoms and severity measures, and also between patients and healthy subjects. Upon these comparisons, biomarkers will be established for the patient population.'}], 'secondaryOutcomes': [{'measure': 'PBMC cell types frequencies', 'timeFrame': '1 year', 'description': 'PBMC cell types frequencies, derived from single cell sequencing and mass spectrometry, will be compared for the same patient before and after treatment, among patients of different symptoms and severity measures, and also between patients and healthy subjects.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uveitis', 'Diabetic Retinopathy', 'Age-related Macular Degeneration', 'Polypoidal Choroidal Vasculopathy', 'VKH Syndrome', 'Behçet Disease']}, 'descriptionModule': {'briefSummary': 'To identify biomarkers of common eye diseases based on single-cell sequencing technologies using PBMC samples. These diseases include uveitis, diabetic retinopathy, age-related macular degeneration and polypoid choroidal vasculopathy. Our study may provide new insight into the underlying mechanisms, and reveal novel predictors and intervention targets for the diagnosis, prognosis and treatment of these diseases.', 'detailedDescription': "The pathogenesis of common eye diseases such as uveitis (including Behcet's disease (BD) and Vogt-Koyanagi-Harada disease (VKH)), diabetic retinopathy (DR), age-related macular degeneration (AMD) and polypoid choroidal vasculopathy (PCV) remains unknown. Although immunosuppressants, anti-vascular endothelial growth factor (VEGF) agents, and pars plana vitrectomy (PPV) have been widely used for treatment, the current therapeutic options are limited. In addition, there is a lack of biomarkers to indicate the prognosis and treatment response of these diseases. The aim of this study is to identify biomarkers and to provide a new target for individualized diagnosis and treatment of common eye diseases based on single cell sequencing technology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects and patients who are diagnosed as DR, VKH, BD, AMD, or PCV will be enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n1. Age over 18 (including 18 years old);\n2. Clinically diagnosed as diabetic retinopathy (DR), uveitis (VKH or BD) , age-related macular degeneration (AMD) , or polypoid choroidal vasculopathy (PCV)\n\nExclusion Criteria for patients with retinal diseases:\n\n1. Have received more than 2 intravitreal injections of anti-VEGF drugs because of retinal or choroidal neovascularization and macular edema;\n2. Patients with stable condition after having undergone panretinal laser photocoagulation and pars plana vitrectomy (PPV);\n3. There are other serious systemic diseases of the body, such as history of chronic kidney disease requiring dialysis or a kidney transplant, unstable blood pressure, cardiovascular disease, tumors, etc;\n4. Patients who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT04101604', 'briefTitle': 'Biomarkers of Common Eye Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Using Next-Generation Sequencing Technology to Identify Biomarkers of Common Eye Diseases', 'orgStudyIdInfo': {'id': '2019KYPJ114'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with VKH, BD, DR, AMD, or PCV', 'description': 'Collection of blood samples and clinical information from patients with VKH, BD, DR, AMD, or PCV', 'interventionNames': ['Other: Collection of blood samples']}, {'label': 'Healthy subjects', 'description': 'Collection of blood samples and clinical information', 'interventionNames': ['Other: Collection of blood samples']}], 'interventions': [{'name': 'Collection of blood samples', 'type': 'OTHER', 'description': 'Collection of blood samples for DNA extraction and genetic characterization, and for identification of peripheral blood biomarkers using single-cell transcriptomics and mass cytometry.', 'armGroupLabels': ['Healthy subjects', 'Patients with VKH, BD, DR, AMD, or PCV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingfeng Zheng', 'role': 'CONTACT', 'email': 'zhyfeng@mail.sysu.edu.cn', 'phone': '+8613922286455'}], 'facility': 'Zhognshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yingfeng Zheng', 'role': 'CONTACT', 'email': 'zhyfeng@mail.sysu.edu.cn', 'phone': '+8613922286455'}, {'name': 'Yizhi Liu', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Yingfeng Zheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhognshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical investigator', 'investigatorFullName': 'Yingfeng Zheng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}