RECRUITING

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

Description

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.

Conditions

Mouth Diseases
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Related Conditions:

Mouth Diseases

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Mouth Diseases
Intervention / Treatment

-

Contacts and Locations

Birmingham

The University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Loma Linda

Loma Linda University, Loma Linda, California, United States, 92350

Minneapolis

Minnesota Oral and Facial Surgery, Minneapolis, Minnesota, United States, 55415

Houston

MD Anderson Cancer Cetner, Houston, Texas, United States, 44907

Houston

UTHealth Houston School of Dentistry, Houston, Texas, United States, 77054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Proteocyte Diagnostics Inc.,

Simon W Young, DDS, MD, PhD, PRINCIPAL_INVESTIGATOR, UTHealthHouston

Study Record Dates

2024-12