Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue
Conditions
Interventions
Intervention1: BeVigilant OraFusion System Ora-3D BeVigilant Reader OraFusion Software: By comparing this innovative approach to standard biopsy the study aims to evaluate its potential as a semi
Sponsors
Vigilant Biosciences Inc
Eligibility
Inclusion criteria
Inclusion criteria: Aged 22 years or older. Presence of visible oral abnormalities such as leukoplakia erythroplakia or other lesions suggestive of early-stage oral cancer Ability and willingness to provide informed consent, saliva samples, and complete questionnaires Self-reported cancer-free status (no prior history of oral cancer) Demonstrated ability to participate in the study procedures including follow-up visits
Exclusion criteria
Exclusion criteria: Known history of oral cancer or other head and neck cancers Presence of conditions that could interfere with the collection or analysis of saliva samples (e g active oral infections severe dry mouth etc) Pregnant or lactating women Inability or unwillingness to provide informed consent or participate in follow-up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Enhanced accuracy in referrals and early cancer detection leading to improved survival ratesTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Streamlined processes for both patients & healthcare providers improving efficiency & reducing wait times Timepoint: Baseline (Pre-implementation): Capture current process duration (e g sample collection to results consultation turnaround) At Point-of-Care (Day 0): During first use of the device measure time from sample to result 2 Weeks Post-Implementation: Evaluate efficiency from both provider & patient perspectives 3 Months Post-Implementation: Assess process improvements sustained over time including overall reduction in wait times & throughput;Increased peace of mind for patients & clinicians especially when the care pathway is unclear Timepoint: Pre-Test (Day 0): Use patient/clinician-reported scales (eg anxiety or decisional conflict scales) before bioassay Immediately Post-Test (Within 30 minutes): Assess psychological response to near-instant results 1 Week Post-Test: Evaluate peace of mind based on diagnostic clarity or follow-up planning 1 Month Post-Test: Longer-term reflection on the emotional impact & confidence in care pathway decisions;A sense of urgency for clinicians & patients to address high-risk cases promptly Timepoint: At Diagnosis (Day 0): Measure time to communicate result once bioassay indicates high-risk biomarkers Within 24 48 Hours: Record initiation of referral imaging biopsy or additional diagnostics 1 Week Post-Result: Assess scheduling of definitive management steps (e g specialist appointment treatment planning) 1 Month Post-Result: Track any delay or completion in initiating management;A point-of-care device that provides near-instant results (approximately 10 minutes) empowering clinicians with timely decision-makingTimepoint: Day 0 (First Use): Record time between sample collection & clinical decision-making Immediately Post-Test: Collect clinician-reported confidence & decisiveness (via short survey or rating scale) 1 Week Post-Test: Evaluate whether early decisions were upheld or altered with confirmatory test | — |
Countries
India
Contacts
Public ContactDr. Pooja Kunjan
Dr A P J Abdul Kalam Education Research and Incubation Centre
Outcome results
None listed