Evaluation of Oral Potentially Malignant Disorders (OPMDs) With STRATICYTE™
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The study objectives are to:
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Evaluate STRATICYTE™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria.
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Identify patient and clinical characteristics influencing the sensitivity and specificity of the STRATICYTE™ model.
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Estimate the correlation between STRATICYTE™ outcome and time to a positive diagnosis of oral cancer.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| OPMDs that progressed to OSCC No dysplasia, mild, moderate, severe dysplasia, CIS |
Other: STRATICYTE™ Test
Assessment for risk of progression to oral cancer
Other Names:
|
| OPMDs that did not progress to OSCC No dysplasia, mild, moderate, severe dysplasia, CIS |
Other: STRATICYTE™ Test
Assessment for risk of progression to oral cancer
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and Specificity [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 [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.
Secondary Outcome Measures
- AUC [5 years]
Area under the receiver operator curve
- C-index (Harrell's) [5 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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Patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with:
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No histological evidence of cancer with clinical follow-up data for a period of at least five years; or
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OSCC development (histologic or documented evidence of invasive cancer).
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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:
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | Loma Linda University | Loma Linda | California | United States | 92350 |
| 3 | Minnesota Oral and Facial Surgery | Minneapolis | Minnesota | United States | 55415 |
| 4 | UTHealth Houston School of Dentistry | Houston | Texas | United States | 77054 |
Sponsors and Collaborators
- Proteocyte Diagnostics Inc.
- The University of Texas Health Science Center, Houston
- Loma Linda University
- Minnesota Oral & Facial Surgery
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Simon W Young, DDS, MD, PhD, UTHealthHouston
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- PRO-STR-PPOEL-2