To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
NCT ID:
NCT05853783
Condition:
Mouth Diseases
Conditions: Official terms:
Mouth Diseases
Conditions: Keywords:
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
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
STRATICYTE™ Test
Description:
Assessment for risk of progression to oral cancer
Arm group label:
OPMDs that did not progress to OSCC
Arm group label:
OPMDs that progressed to OSCC
Other name:
S100A7 Immunohistochemistry Signature-based Test
Summary:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Completed
Facility:
Name:
Loma Linda University
Address:
City:
Loma Linda
Zip:
92350
Country:
United States
Status:
Completed
Facility:
Name:
Minnesota Oral and Facial Surgery
Address:
City:
Minneapolis
Zip:
55415
Country:
United States
Status:
Withdrawn
Facility:
Name:
MD Anderson Cancer Cetner
Address:
City:
Houston
Zip:
44907
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew G Sikora, MD, PhD
Facility:
Name:
UTHealth Houston School of Dentistry
Address:
City:
Houston
Zip:
77054
Country:
United States
Status:
Completed
Start date:
January 1, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Proteocyte Diagnostics Inc.
Agency class:
Industry
Collaborator:
Agency:
The University of Texas Health Science Center, Houston
Agency class:
Other
Collaborator:
Agency:
Loma Linda University
Agency class:
Other
Collaborator:
Agency:
Minnesota Oral & Facial Surgery
Agency class:
Other
Collaborator:
Agency:
University of Alabama at Birmingham
Agency class:
Other
Source:
Proteocyte Diagnostics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05853783
https://www.medlior.com/
https://oralcancerfoundation.org/
https://proteocyte.com
