Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02685956
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jen.maas@globalbioclinical.com', 'phone': '206-240-8632', 'title': 'Jennifer Maas', 'organization': 'Global BioClinical'}, 'certainAgreement': {'otherDetails': 'Sponsor has 45 days to review and comment. Sponsor may extend the embargo period for no more than an additional 60 days in order to file a patent application due to patentable subject matter contained in the proposed presentation or publication. If the Sponsor objects to the publication or presentation due to the existence of confidential information, the institution shall remove the confidential information before disclosure.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'This trial utilized remnant laboratory specimens and all results were monitored for accuracy and adverse events upon the completion of the testing phase of the study.', 'description': 'This is a remnant sample study using leftover HSV swab sample media. All case data was fully monitored on completion of the testing phase of the study and no adverse events associated with study subjects contributing biospecimens were identified..\n\nThere was also reporting mechanism in place to record device user adverse events however no in vitro diagnostic device user adverse events were reported in the study', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Lesions', 'description': 'Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Anogenital Lesions', 'description': 'Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '1291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anogenital Lesions With POSITIVE HSV1 ELVIS Result', 'description': 'Sample collected from an anogenital lesion and tested positive for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)'}, {'id': 'OG001', 'title': 'Anogenital Lesions With Negative HSV1 ELVIS Result', 'description': 'Sample collected from an anogenital lesion and tested negative for HSV1 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)'}], 'classes': [{'title': 'HSV-1 POSITIVE by SA201 HSV-1/2 PCR Test', 'categories': [{'measurements': [{'value': '281', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'HSV-1 NEGATIVE by SA201 HSV-1/2 PCR Test', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1237', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 60 days of last sample enrollment', 'description': 'Study will assesses Sentosa HSV 1/2 assay fpr detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group included samples from 290 anogenital and 1291 anogenital lesions tested for HSV1 using the ELVIS HSV ID and D3 Typing Test System (N=1581). A further 397 that tested HSV2 positive by ELVIS were excluded from the HSV1 analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '1581', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anogenital Lesions With POSITIVE HSV2 ELVIS Result', 'description': 'Sample collected from an anogenital lesion and tested positive for HSV2 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)'}, {'id': 'OG001', 'title': 'Anogenital Lesions With NEGATIVE HSV2 ELVIS Result', 'description': 'Sample collected from an anogenital lesion and tested negative for HSV2 using the ELVIS HSV ID and D3 Typing Test System (ELVIS)'}], 'classes': [{'title': 'HSV-2 POSITIVE by SA201 HSV-1/2 PCR Test', 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'HSV-2 NEGATIVE by SA201 HSV-1/2 PCR Test', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1434', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 60 days of last sample enrollment', 'description': 'Study asses Sentosa HSV 1/2 assay in detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group included samples from N=1978 anogenital lesions tested for HSV2 using the ELVIS HSV ID and D3 Typing Test System.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Lesions', 'description': 'Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.'}, {'id': 'FG001', 'title': 'Anogenital Lesions', 'description': 'Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '317'}, {'groupId': 'FG001', 'numSubjects': '1978'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '317'}, {'groupId': 'FG001', 'numSubjects': '1978'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Lesions', 'description': 'Male and female subjects of any age with sample collected from an oral lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.'}, {'id': 'BG001', 'title': 'Anogenital Lesions', 'description': 'Male and female subjects of any age with sample collected from an anogenital lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '0 - 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': '11 - 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}, {'title': '21 - 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '684', 'groupId': 'BG001'}, {'value': '750', 'groupId': 'BG002'}]}]}, {'title': '31 - 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '378', 'groupId': 'BG001'}, {'value': '418', 'groupId': 'BG002'}]}]}, {'title': '41 - 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}, {'title': '51 - 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': '61 - 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': '71 - 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': '81 - 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': '>90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '1573', 'groupId': 'BG001'}, {'value': '1753', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '405', 'groupId': 'BG001'}, {'value': '542', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '317', 'groupId': 'BG000'}, {'value': '1978', 'groupId': 'BG001'}, {'value': '2295', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-16', 'size': 1339485, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-17T03:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples collected from an oral or genital site, submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2.\n\nSamples collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2295}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2016-02-10', 'resultsFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2016-02-18', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-18', 'studyFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Positive and Negative for HSV-1 by SA201 HSV-1/2 PCR Test', 'timeFrame': 'within 60 days of last sample enrollment', 'description': 'Study will assesses Sentosa HSV 1/2 assay fpr detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).'}, {'measure': 'Number of Participants Positive and Negative for HSV-2 by SA201 HSV-1/2 PCR Test', 'timeFrame': 'within 60 days of last sample enrollment', 'description': 'Study asses Sentosa HSV 1/2 assay in detecting HSV DNA compared to traditional microbiology culture-based ELVIS method (reference assay). HSV DNA detection is determined for each virus (HSV 1 and 2) at each type of anatomic site (genital lesion and oral lesion).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Herpes Simplex']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.veladx.com/', 'label': 'Vela Diagnostics Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative PCR Test. Precision of results and concordance of results with a reference assay will be evaluated.', 'detailedDescription': 'This study will utilize residual samples from male and female patients with signs and symptoms of oral or genital HSV infections. Genital samples will include internal and external genital lesions such as those collected from lesions of the anus, buttocks, vagina, labia, or penis. Oral samples will include those collected from lip, gum, and mouth lesions. For concordance testing, the sample size is based on historical study design and estimates of the expected prevalence of HSV1 and/or HSV2 in the population enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and females with genital or oral lesions to be tested for HSV 1/2 infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sample was taken from a lesion from an internal or external oral or genital site.\n* Sample was submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2.\n* The following information about the patient from which the sample was taken is available: presumptive diagnosis or signs and symptoms causing assay requisition; site of lesion; age at time of sample collection or date of birth, and sex.\n* Sample was collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.\n* There is sufficient residual sample to perform both test and reference assays.\n\nExclusion Criteria:\n\n* Sample leaked during shipment or storage prior to assay.\n* Sample has undergone more than 1 freeze-thaw cycle before testing;\n* Sample eluent is not clear after centrifugation (refer to section 6.3.1).\n* Sample ID is missing or ambiguous.\n* Sample is collected using alginate calcium swab.\n* Sample handling and storage requirement in section 5.4 not followed'}, 'identificationModule': {'nctId': 'NCT02685956', 'briefTitle': 'Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vela Diagnostics'}, 'officialTitle': 'Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test', 'orgStudyIdInfo': {'id': 'Vela Sentosa HSV Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vela Sentosa SA HSV1/2 PCR Test', 'description': 'Male and female subjects of any age with sample collected from a lesion and submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2 and diagnosing HSV infection.', 'interventionNames': ['Device: Vela Sentosa SA HSV1/2 Qualitative PCR Test']}], 'interventions': [{'name': 'Vela Sentosa SA HSV1/2 Qualitative PCR Test', 'type': 'DEVICE', 'otherNames': ['Sentosa HSV Assay'], 'description': 'medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test', 'armGroupLabels': ['Vela Sentosa SA HSV1/2 PCR Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Health', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Health', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '07407', 'city': 'Elmwood Park', 'state': 'New Jersey', 'country': 'United States', 'facility': 'BioReference Labs', 'geoPoint': {'lat': 40.90399, 'lon': -74.11848}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '19044', 'city': 'Horsham', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Quest Diagnostics', 'geoPoint': {'lat': 40.17844, 'lon': -75.12851}}, {'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75067', 'city': 'Lewisville', 'state': 'Texas', 'country': 'United States', 'facility': 'MedFusion', 'geoPoint': {'lat': 33.04623, 'lon': -96.99417}}], 'overallOfficials': [{'name': 'Shaw Chiat Hong', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vela Diagnostics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vela Diagnostics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}