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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
- ClinicalTrials.gov ID
- NCT05853783
- Acronym / sponsor ID
- PRO-STR-PPOEL-2
- Conditions
- Mouth Diseases
- Keywords
- Leukoplakia, Erythroplakia, Erythroleukoplakia, Lesion, Oral epithelial dysplasia, S100A7 biomarker, S100A7 Immunohistochemistry Signature-based, Early Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Proteocyte Diagnostics Inc.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
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPMDs that progressed to OSCC | – | Other: STRATICYTE™ TestNo dysplasia, mild, moderate, severe dysplasia, CIS |
| OPMDs that did not progress to OSCC | – | Other: STRATICYTE™ TestNo dysplasia, mild, moderate, severe dysplasia, CIS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRATICYTE™ TestAlso: S100A7 Immunohistochemistry Signature-based TestAssessment for risk of progression to oral cancer | Other | OPMDs that did not progress to OSCC, OPMDs that progressed to OSCC |
Primary outcome
Sensitivity and Specificity
Time frame: 5 years
Standard measures of accuracy calculated using cross-tabulation of predicted risk category and confirmed cancer progression over a 5-year period from biopsy
Survival analysis
Time frame: 5 years
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.
2 secondary outcomes
AUC
Time frame: 5 years
C-index (Harrell's)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 41054469Hwang 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.
- Background: PubMed 18339795Ralhan 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.
- Background: PubMed 19072117Ralhan 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.
- Background: PubMed 20689826Tripathi 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.
- Background: PubMed 24122701Kaur 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.
- Background: PubMed 28110942Hwang 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.
- Medlior Health Outcomes ResearchLink provided by the sponsor.
- Oral Cancer FoundationLink provided by the sponsor.
- Proteocyte Diagnostics Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon W Young, DDS, MD, PhD principal investigator
UTHealthHouston
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mouth Diseases, run by Proteocyte Diagnostics Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jody Filkowski, BSc, MSc, PhD (1-825-305-0749, Jody.Filkowski@medlior.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853783, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.