Clinical trial · Observational
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
Detection of Oral and Throat Cancers Using Saliva Metatranscriptomic Analysis
NCT05451303CI-TRIAL-00085268recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Premalignant Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OralViome Cancer Testing System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- 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: * Dysplasia * Hyperplasia * Leukoplakia * Erythroplasia * Lichenoid lesions * Actinic Keratosis * Lichenoid reaction * Aphthous ulcer/ Canker Sores * Gingival enlargement (side effect) * Lichen planus * Keratosis * Inflammatory reaction * Cheek bites
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Signed Informed Consent obtained * 18 years and older * At a high risk of developing oral or throat cancer based on clinician's discretion Exclusion Criteria * Pregnancy * Use of fertility enhancing medications
References
Publications (0)
Data not yet available
No reference posted for this study.