Trials / Recruiting
RecruitingNCT05853783
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 180 (estimated)
- Sponsor
- Proteocyte Diagnostics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective cohort of patients who received biopsies.
Detailed description
The study objectives are to: 1. Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria. 2. Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model. 3. Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | STRATICYTE™ Test | Assessment for risk of progression to oral cancer |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2023-05-11
- Last updated
- 2024-11-07
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05853783. Inclusion in this directory is not an endorsement.