Clinical trial NCT05853783: Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
Official title: Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mouth Diseases
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
Lead sponsor: Proteocyte Diagnostics Inc.
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Health Science Center, Houston
name: Loma Linda University
name: Minnesota Oral & Facial Surgery
name: University of Alabama at Birmingham
First posted: 2023-05-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 5 years
measure: Survival analysis
timeFrame: 5 years
Secondary outcomes:
measure: AUC
timeFrame: 5 years
measure: C-index (Harrell's)
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Minneapolis
country: United States
facility: Minnesota Oral and Facial Surgery
state: Minnesota
city: Houston
country: United States
facility: MD Anderson Cancer Cetner
state: Texas
city: Houston
country: United States
facility: UTHealth Houston School of Dentistry
state: Texas
Study officials:
affiliation: UTHealthHouston
name: Simon W Young, DDS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hwang, J.T.K., Dammling, C., McCord, C. et al. External Validation of Straticyte™, a Quantitative Biomarker-Based Risk Assay in Predicting Oral Cancer. J. Maxillofac. Oral Surg. (2024). https://doi.org/10.1007/s12663-024-02362-7
citation: Ralhan R, Desouza LV, Matta A, Tripathi SC, Ghanny S, Datta Gupta S, Bahadur S, Siu KW. Discovery and verification of head-and-neck cancer biomarkers by differential protein expression analysis using iTRAQ labeling, multidimensional liquid chromatography, and tandem mass spectrometry. Mol Cell Proteomics. 2008 Jun;7(6):1162-73. doi: 10.1074/mcp.M700500-MCP200. Epub 2008 Mar 13.
citation: Ralhan R, Desouza LV, Matta A, Tripathi SC, Ghanny S, Dattagupta S, Thakar A, Chauhan SS, Siu KW. iTRAQ-multidimensional liquid chromatography and tandem mass spectrometry-based identification of potential biomarkers of oral epithelial dysplasia and novel networks between inflammation and premalignancy. J Proteome Res. 2009 Jan;8(1):300-9. doi: 10.1021/pr800501j.
citation: Tripathi SC, Matta A, Kaur J, Grigull J, Chauhan SS, Thakar A, Shukla NK, Duggal R, DattaGupta S, Ralhan R, Siu KW. Nuclear S100A7 is associated with poor prognosis in head and neck cancer. PLoS One. 2010 Aug 3;5(8):e11939. doi: 10.1371/journal.pone.0011939.
citation: Kaur J, Matta A, Kak I, Srivastava G, Assi J, Leong I, Witterick I, Colgan TJ, Macmillan C, Siu KW, Walfish PG, Ralhan R. S100A7 overexpression is a predictive marker for high risk of malignant transformation in oral dysplasia. Int J Cancer. 2014 Mar 15;134(6):1379-88. doi: 10.1002/ijc.28473. Epub 2013 Oct 8.
citation: Hwang JT, Gu YR, Shen M, Ralhan R, Walfish PG, Pritzker KP, Mock D. Individualized five-year risk assessment for oral premalignant lesion progression to cancer. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Mar;123(3):374-381. doi: 10.1016/j.oooo.2016.11.004. Epub 2016 Nov 22.