RECRUITING

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

Talk to us

Conditions

Mouth DiseasesLeukoplakiaErythroplakiaErythroleukoplakiaLesionOral epithelial dysplasiaS100A7 biomarkerS100A7 Immunohistochemistry Signature-basedEarly DiagnosisSTRATICYTEOral neoplasiaOral epithelial atypiaHyperplasiaHyperkeratosisPotentially premalignant oral epithelial lesionOral potentially malignant disordersMild dysplasiaModerate dysplasiaSevere dysplasiaLow-grade dyspalsiaHigh-grade dysplasiaPersonalized medicinePredictive AssayWhole slide imagingComputational pathologyDigital pathologyOral potentially malignant lesion

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-01
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05853783

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with:
  3. * No histological evidence of cancer with clinical follow-up data for a period of at least five years; or
  4. * OSCC development (histologic or documented evidence of invasive cancer).
  5. * Patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center.
  1. * 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.
  2. * 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.

Contacts and Locations

Study Contact

Jody Filkowski, BSc, MSc, PhD
CONTACT
1-825-305-0749
Jody.Filkowski@medlior.com
Jason TK Hwang, HBSc, MSc, PhD
CONTACT
1-647-255-1370
jhwang@proteocyte.com

Principal Investigator

Simon W Young, DDS, MD, PhD
PRINCIPAL_INVESTIGATOR
UTHealthHouston

Study Locations (Sites)

The University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Loma Linda University
Loma Linda, California, 92350
United States
Minnesota Oral and Facial Surgery
Minneapolis, Minnesota, 55415
United States
MD Anderson Cancer Cetner
Houston, Texas, 44907
United States
UTHealth Houston School of Dentistry
Houston, Texas, 77054
United States

Collaborators and Investigators

Sponsor: Proteocyte Diagnostics Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Leukoplakia
  • Erythroplakia
  • Erythroleukoplakia
  • Lesion
  • Oral epithelial dysplasia
  • S100A7 biomarker
  • S100A7 Immunohistochemistry Signature-based
  • Early Diagnosis
  • STRATICYTE
  • Oral neoplasia
  • Oral epithelial atypia
  • Hyperplasia
  • Hyperkeratosis
  • Potentially premalignant oral epithelial lesion
  • Oral potentially malignant disorders
  • Mild dysplasia
  • Moderate dysplasia
  • Severe dysplasia
  • Low-grade dyspalsia
  • High-grade dysplasia
  • Personalized medicine
  • Predictive Assay
  • Whole slide imaging
  • Computational pathology
  • Digital pathology
  • Oral potentially malignant lesion

Additional Relevant MeSH Terms

  • Mouth Diseases