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

Proteocyte Diagnostics

Status: Enrolling

Conditions: Mouth Diseases

Treatments: Other: STRATICYTE™ Test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05853783

PRO-STR-PPOEL-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with:
• 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.

Exclusion criteria

• 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

180 participants in 2 patient groups

OPMDs that progressed to OSCC

Description:

No dysplasia, mild, moderate, severe dysplasia, CIS

Treatment:

Other: STRATICYTE™ Test

OPMDs that did not progress to OSCC

Description:

No dysplasia, mild, moderate, severe dysplasia, CIS

Treatment:

Other: STRATICYTE™ Test