Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Proteocyte Diagnostics Inc.
- Study ID
- NCT05853783
- Status
- Recruiting
Conditions
- Mouth Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- STRATICYTE™ Test — OTHERAssessment for risk of progression to oral cancer
Study Details
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.
Key Dates
- Start date
- Jan 1, 2023
- Status verified
- Nov 2024
- Primary completion
- Dec 31, 2024
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 180 participants (estimated)
Arms
- Arm: OPMDs that progressed to OSCCNo dysplasia, mild, moderate, severe dysplasia, CIS
- Arm: OPMDs that did not progress to OSCCNo dysplasia, mild, moderate, severe dysplasia, CIS
Primary Outcome Measure
Sensitivity and Specificity [ Time Frame: 5 years ]
Central Contacts
- Jody Filkowski, BSc, MSc, PhD1-825-305-0749
- Jason TK Hwang, HBSc, MSc, PhD1-647-255-1370
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | - |
| Loma Linda University | Loma Linda | California | 92350 | - |
| Minnesota Oral and Facial Surgery | Minneapolis | Minnesota | 55415 | - |
| MD Anderson Cancer Cetner | Houston | Texas | 44907 | Andrew G Sikora, MD, PhD |
| UTHealth Houston School of Dentistry | Houston | Texas | 77054 | - |