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Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 7, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Aug 2024 to Dec 2024
    • Site contacts updated at 1 of 5 sites
    • Publications: 5 to 6
    v3
  2. Primary completion date: Oct 2023 to Aug 2024
    • Study sites: 4 to 5
    • Study completion date: Apr 2024 to Dec 2024
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05853783
Lead Sponsor Proteocyte Diagnostics Inc.
Collaborators: The University of Texas Health Science Center, Houston, Loma Linda University, Minnesota Oral & Facial Surgery, University of Alabama at Birmingham
Conditions
(from sponsor)		 Mouth Diseases
Related terms Disease, Erythroplasia, Hyperplasia, Keratoderma, Palmoplantar, Epidermolytic, Leukoplakia, Mouth Diseases
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov