Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
NCT ID: NCT05853783
Last Updated: 2024-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2023-01-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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OPMDs that progressed to OSCC
No dysplasia, mild, moderate, severe dysplasia, CIS
STRATICYTE™ Test
Assessment for risk of progression to oral cancer
OPMDs that did not progress to OSCC
No dysplasia, mild, moderate, severe dysplasia, CIS
STRATICYTE™ Test
Assessment for risk of progression to oral cancer
Interventions
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STRATICYTE™ Test
Assessment for risk of progression to oral cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Loma Linda University
OTHER
Minnesota Oral & Facial Surgery
UNKNOWN
University of Alabama at Birmingham
OTHER
Proteocyte Diagnostics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Simon W Young, DDS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UTHealthHouston
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Loma Linda University
Loma Linda, California, United States
Minnesota Oral and Facial Surgery
Minneapolis, Minnesota, United States
MD Anderson Cancer Cetner
Houston, Texas, United States
UTHealth Houston School of Dentistry
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Andrew G Sikora, MD, PhD
Role: primary
References
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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
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.
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.
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.
Related Links
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Medlior Health Outcomes Research
Oral Cancer Foundation
Proteocyte Diagnostics Inc.
Other Identifiers
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PRO-STR-PPOEL-2
Identifier Type: -
Identifier Source: org_study_id
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