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NCT05853783 · ClinicalTrials.gov registry record
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
A clinical trial of Mouth Diseases, sponsored by Proteocyte Diagnostics.
- Recruiting
- Registry status
- 180
- Enrollment target
- 5
- Study locations
NCT05853783: Recruiting study of Mouth Diseases, sponsored by Proteocyte Diagnostics.
NCT05853783 is a study of Mouth Diseases that is actively recruiting participants, run by Proteocyte Diagnostics. The registered enrollment target is 180 participants. The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05853783, a study of Mouth Diseases, is actively recruiting participants, sponsored by Proteocyte Diagnostics.
- RECRUITING
- Registry status
- 180 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy
Conditions Studied
Interventions
- OTHER STRATICYTE™ Test
Study Locations (5)
Texas
- MD Anderson Cancer Cetner - Houston
- UTHealth Houston School of Dentistry - Houston
Alabama
- The University of Alabama at Birmingham - Birmingham
California
- Loma Linda University - Loma Linda
Minnesota
- Minnesota Oral and Facial Surgery - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2024-12 |
What NCT05853783 shows while recruiting
NCT05853783 is an observational study that tracks outcomes without assigning an intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Mouth Diseases appearing as the primary indexed condition, and to 1 intervention - of which STRATICYTE™ Test is the first listed.
NCT05853783 lists 5 locations in 4 states (Texas, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT05853783 about?
NCT05853783 is a clinical study titled "Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™". 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.
What is the current status of trial NCT05853783?
This trial is currently recruiting. The enrollment target is 180 participants. The study started on 2023-01-01. Estimated completion is 2024-12.
What conditions does trial NCT05853783 study?
This clinical trial studies the following conditions: Mouth Diseases.
What interventions are being tested in trial NCT05853783?
The interventions under investigation include: STRATICYTE™ Test (OTHER).
Who is sponsoring clinical trial NCT05853783?
This trial is sponsored by Proteocyte Diagnostics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05853783 being conducted?
This trial has 5 study locations across Alabama, California, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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