Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
ConditionMouth Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorProteocyte Diagnostics Inc.
About this trial
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.
Eligibility criteria
Qualifiers
From the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system)
No histological evidence of cancer with clinical follow-up data for a period of at least five years; or
OSCC development (histologic or documented evidence of invasive cancer).
Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center.
Disqualifiers
Patients with oral lesions or dysplasia with no indication of OSCC development or follow-up data of less than five years in non-OSCC patients.
Patients diagnosed with oral epithelial dysplasia concomitant with OSCC at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.
Trial design
Treatments tested in this trial
- STRATICYTE™ Test
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Proteocyte Diagnostics Inc.
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborator
Loma Linda University
Collaborator
Minnesota Oral & Facial Surgery
Collaborator
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov