Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

The target population are patients presenting with an OPMD who have received a biopsy of their lesion. The study sample will be composed of patients with previously biopsied OPMDs from contracted clinics.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • STRATICYTE™ Test

    Other intervention

    Assessment for risk of progression to oral cancer

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: OPMDs that progressed to OSCC1 intervention
Group B: OPMDs that did not progress to OSCC1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity and Specificity

Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy

Time frame
5 years
2

Survival analysis

Kaplan-Meier analyses to compare time to a positive diagnosis of oral cancer between patients/biopsies with a STRATICYTE™ classification of Low- and Elevated-Risk.

Time frame
5 years

Secondary outcomes

1

AUC

Area under the receiver operator curve

Time frame
5 years
2

C-index (Harrell's)

From all possible pairs of patients, compute the number of concordant and discordant pairs. Compute C-index as the proportion of all possible pairs that are concordant.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
Apply now