Mouth DiseasesNCT05853783
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
An observational study of Mouth Diseases, run by Proteocyte Diagnostics Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mouth Diseases
- What is being tested?
- STRATICYTE™ Test
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jan 2023to Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 1 recruiting
- Completed
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
- Recruiting
MD Anderson Cancer Cetner
Houston, Texas, 44907
Andrew G Sikora, MD, PhD
- Completed
UTHealth Houston School of Dentistry
Houston, Texas, 77054
- Completed
Loma Linda University
Loma Linda, California, 92350
- Withdrawn
Minnesota Oral and Facial Surgery
Minneapolis, Minnesota, 55415
About this study
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.
Read the detailed description
The study objectives are to:
- Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria.
- Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model.
- Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.
- Conditions
- Mouth Diseases
- Being tested
- STRATICYTE™ Test
- 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
- Medical subject headings
- Mouth Diseases, Leukoplakia, Erythroplasia, Disease, Hyperplasia, Keratoderma, Palmoplantar, Epidermolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRATICYTE™ TestOther
Also called S100A7 Immunohistochemistry Signature-based Test
Assessment for risk of progression to oral cancer
| Study group | Role | What they receive |
|---|---|---|
| OPMDs that progressed to OSCC | No dysplasia, mild, moderate, severe dysplasia, CIS Receives: Other: STRATICYTE™ Test | |
| OPMDs that did not progress to OSCC | No dysplasia, mild, moderate, severe dysplasia, CIS Receives: Other: STRATICYTE™ Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy
Measured: 5 years
Survival analysis
Kaplan-Meier analyses to compare time to a positive diagnosis of oral cancer between patients/biopsies with a STRATICYTE™ classification of Low- and Elevated-Risk.
Measured: 5 years
Secondary outcomes (2)
AUC
Area under the receiver operator curve
Measured: 5 years
C-index (Harrell's)
From all possible pairs of patients, compute the number of concordant and discordant pairs. Compute C-index as the proportion of all possible pairs that are concordant.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mouth DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proteocyte Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center, Houston, Loma Linda University, Minnesota Oral & Facial Surgery, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Simon W Young, DDS, MD, PhD, Principal investigator, UTHealthHouston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853783
- Sponsor's protocol ID
- PRO-STR-PPOEL-2
- Status last verified
- Nov 2024
- First submitted
- 2 May 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang JTK, Dammling C, McCord C, McGuire T, Park EP, Filkowski J, Shaw E, McMullen S, Nwigwe A, Ekwaru JP, McGaw WT, Lung KE, Seikaly H, Renick B, Lin DM, Morlandt A, Pritzker KH, Darling MR. External Validation of Straticyte, a Quantitative Biomarker-Based Risk Assay in Predicting Oral Cancer. J Maxillofac Oral Surg. 2025 Oct;24(5):1351-1357. doi: 10.1007/s12663-024-02362-7. Epub 2024 Oct 29.
PubMed 41054469Ralhan 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.
PubMed 18339795Ralhan 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.
PubMed 19072117Tripathi 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.
PubMed 20689826Kaur 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.
PubMed 24122701Hwang 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.
PubMed 28110942