Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 4:58 AM
Study NCT ID:
NCT05102994
Status:
UNKNOWN
Last Update Posted:
2021-11-15
First Post:
2021-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mutation Detection for VRL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064090', 'term': 'Intraocular Lymphoma'}, {'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Combined ocular manifestations with the results of pathology, IL-10/IL-6 ratio, IGH gene rearrangements and patients' response to treatments, patients abtained clear diagnosis"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-11-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2021-10-17', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the result of mutation test', 'timeFrame': 'at baseline, before treatment', 'description': 'any mutation detect in intraocular fluild recorded as ctDNA+'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitreoretinal lymphoma', 'Uveitis', 'intraocular fluid', 'mutation'], 'conditions': ['Vitreoretinal Lymphoma', 'Uveitis']}, 'descriptionModule': {'briefSummary': 'Vitreoretinal lymphoma (VRL) is a rare but aggressive masquerade syndrome, which would be easily confused with uveitis. The diagnostic gold standard remains the pathologic examination of ocular specimen with invasiveness and low sensitivity. To improve the safety and accuracy of VRL diagnosis, alternative techniques using intraocular fluid (IOF) samples are emerging. In this study, we aimed to test the diagnostic value of mutation analysis for VRL', 'detailedDescription': 'chest CT, urinalysis, kidney, and liver function were routinely checked.\n\nIL-10/IL-6 ratio, genetic mutation analysis and samples were IGH gene rearrangements were reviewed and analyzed retrospectively.\n\nThe diagnoses were identified after careful evaluation of treatment effects in follow-up. The diagnostic value including sensitivity, specificity, positive and negative predictive values, and test efficiency of genetic mutation analysis in diagnosing VRL were analyzed.\n\nFurthermore, a validation group of patients including VRL and uveitis was selected to validate the diagnostic value of mutation analysis in the diagnosis of VRL. All the patients signed an informed consent and institutional review board approval was obtained. The study was performed in accordance with the tenets of the Declaration of Helsinki.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'suspected VRL or uveitis patients attending to our clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected VRL patients who had intraocular fluid for mutation test. And got a clear diagnose of VRL or uveitis afther having dianostic tests and follow-up treatment\n\nExclusion Criteria:\n\n* suspected VRL patients who lost in follow-up without a definitive diagnose, or whoever reluctance to participate our study'}, 'identificationModule': {'nctId': 'NCT05102994', 'briefTitle': 'Mutation Detection for VRL', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Diagnostic Value of Mutation Detection for VRL', 'orgStudyIdInfo': {'id': '2021-VRL-diagnosis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VRL patients group', 'description': 'Presenting clinical features suggestive for VRL with positive finding in laboratory exam', 'interventionNames': ['Diagnostic Test: mutation test']}, {'label': 'uveitis group', 'description': 'Even if characterized as clinical features of presumed VRL, no positive laboratory investigations for lymphoma and well response to IMT', 'interventionNames': ['Diagnostic Test: mutation test']}], 'interventions': [{'name': 'mutation test', 'type': 'DIAGNOSTIC_TEST', 'description': 'detect the tumor-related mutation in introcular fluid', 'armGroupLabels': ['VRL patients group', 'uveitis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Dan D Liang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Dan Liang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}