Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
Purpose
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.
Condition
- Mouth Diseases
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| OPMDs that progressed to OSCC | No dysplasia, mild, moderate, severe dysplasia, CIS |
|
| OPMDs that did not progress to OSCC | No dysplasia, mild, moderate, severe dysplasia, CIS |
|
Recruiting Locations
MD Anderson Cancer Cetner
Houston, Texas 44907
Houston, Texas 44907
Contact:
Andrew G Sikora, MD, PhD
Andrew G Sikora, MD, PhD
More Details
- Status
- Recruiting
- Sponsor
- Proteocyte Diagnostics Inc.
Detailed 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.