Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 1:58 AM
Study NCT ID:
NCT05451303
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2022-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 475}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2022-07-05', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint will be the detection or not of OSCC or OPC', 'timeFrame': '1 year', 'description': 'The test results will be compared against the definitive diagnosis by the physician.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Viome', 'oral cancer', 'detection', 'OSCC', 'OPMD-B', 'OPMD-PM', 'OPMD', 'OPV', 'Tobacco', 'HPV'], 'conditions': ['Oral Squamous Cell Carcinoma', 'Oropharynx Squamous Cell Carcinoma', 'Premalignant Lesion']}, 'descriptionModule': {'briefSummary': 'To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.', 'detailedDescription': 'This is an observational study evaluating the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic.\n\nA total of 475 participants will be recruited, including 4 different cohorts: 1) cancer free patients, 2) patients with Oral Potentially Malignant Disease (OPMD), 3) patients with Oral Squamous Cell Carcinoma (OSCC), and 4) patients with OroPharyngeal Cancer (OPC). OSCC and OPC participants will be recruited from secondary care facilities, OPMD and cancer free participants will be recruited from primary care facilities.\n\nParticipants will complete health questionnaires and collect saliva samples using at home/ in clinic kits provided by Viome. The duration of study participation will be 1 clinic visit for cancer free participants, and up to 1 year for those with OSCC/OPC/OPMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited into one of four cohorts, OSCC, OPC, OPMD, or cancer free cohorts.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Signed Informed Consent obtained\n* 18 years and older\n* At a high risk of developing oral or throat cancer based on clinician's discretion\n\nExclusion Criteria\n\n* Pregnancy\n* Use of fertility enhancing medications"}, 'identificationModule': {'nctId': 'NCT05451303', 'briefTitle': 'Detection of Oral and Throat Cancers Using OralViome Cancer Testing System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viome'}, 'officialTitle': 'Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis', 'orgStudyIdInfo': {'id': 'V300'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oral Squamous Cell Carcinoma (OSCC)', 'description': 'OSCC case cohort will consist of patients with Oral Squamous Cell Carcinoma (all stages, locations), recruited from secondary care.', 'interventionNames': ['Device: OralViome Cancer Testing System']}, {'label': 'OroPharyngeal Cancer (OPC)', 'description': 'OPC case cohort will consist of patients with OroPharyngeal cancer (all stages, locations), recruited from secondary care.', 'interventionNames': ['Device: OralViome Cancer Testing System']}, {'label': 'Oral Potentially Malignant Disease (OPMD)', 'description': 'OPMD cohort will consist of patients with both potential malignancies or benign conditions including, but not limited to:\n\n* Dysplasia\n* Hyperplasia\n* Leukoplakia\n* Erythroplasia\n* Lichenoid lesions\n* Actinic Keratosis\n* Lichenoid reaction\n* Aphthous ulcer/ Canker Sores\n* Gingival enlargement (side effect)\n* Lichen planus\n* Keratosis\n* Inflammatory reaction\n* Cheek bites', 'interventionNames': ['Device: OralViome Cancer Testing System']}, {'label': 'Cancer-free', 'description': 'Cancer free control cohort will be matched with cases. Participants will be recruited following clinical adjudication with self-reported confirmation of no cancer and from primary care facilities.', 'interventionNames': ['Device: OralViome Cancer Testing System']}], 'interventions': [{'name': 'OralViome Cancer Testing System', 'type': 'DEVICE', 'description': 'The OralViome Cancer Testing System is intended for the screening of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal cancer (OPC). The system consists of the OralViome Saliva Collection and Transport Kit, the Viome laboratory process for metatranscriptomics, and the Viome analytical software that detects an RNA expression signature within a saliva sample.', 'armGroupLabels': ['Cancer-free', 'Oral Potentially Malignant Disease (OPMD)', 'Oral Squamous Cell Carcinoma (OSCC)', 'OroPharyngeal Cancer (OPC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10595', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mohanapriya Rajamoorthy', 'role': 'CONTACT', 'phone': '(914) 594-4575'}], 'facility': 'NYMC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Mory Mehrtash, MSc', 'role': 'CONTACT', 'email': 'studies@viome.com', 'phone': '425-300-6933'}, {'name': 'Momchilo Vuyisich, PhD', 'role': 'CONTACT', 'email': 'studies@viome.com', 'phone': '425-300-6933'}], 'overallOfficials': [{'name': 'Cristina Julian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Viome'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viome', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'New York Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}