Evidence map›Paper›PMID 41054469›Full record

ArticleJournal of maxillofacial and oral surgery2025

External Validation of Straticyte™, a Quantitative Biomarker-Based Risk Assay in Predicting Oral Cancer.

Jason T K Hwang, Chad Dammling, Christina McCord, Taylor McGuire, E Peter Park, Jody Filkowski, Eileen Shaw, Suzanne McMullen, Adaeze Nwigwe, J Paul Ekwaru and 8 more

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of maxillofacial and oral surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04622462 recruitingnot on this map

A Multi-Centre Prospective Community-Based Observational Study on Prediction of Malignant Progression of Clinically Suspicious Oral Lesions With STRATICYTE

TypeobservationalSponsorProteocyte Diagnostics Inc.Ran2015 to 2026Enrolled500ConditionsOral NeoplasmArmsStandard of Care Histopathology, STRATICYTE Assessment
NCT05853783 recruitingnot on this map

Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™

TypeobservationalSponsorProteocyte Diagnostics Inc.Ran2023 to 2024Enrolled180ConditionsMouth DiseasesArmsSTRATICYTE™ Test
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Jason T K Hwang *Proteocyte Diagnostics Inc., Toronto, ON Canada.ORCID 0000-0001-5191-0950
Chad Dammling *The University of Alabama at Birmingham, Birmingham, AL USA.
Christina McCordDepartment of Pathology and Laboratory Medicine, The University of Western Ontario, 1151 Richmond Street, Health Sciences Addition Room 424, London, ON N6A 5C1 Canada.ORCID 0000-0002-4541-2282
Taylor McGuireArgyle Associates Oral and Maxillofacial Surgery, Ottawa, ON Canada.
E Peter ParkDepartment of Oral and Maxillofacial Surgery, Louisiana State University, New Orleans, LA USA.
Jody FilkowskiMedlior Health Outcomes Research Ltd., Calgary, AB Canada.
Eileen ShawMedlior Health Outcomes Research Ltd., Calgary, AB Canada.
Suzanne McMullenMedlior Health Outcomes Research Ltd., Calgary, AB Canada.
Adaeze NwigweMedlior Health Outcomes Research Ltd., Calgary, AB Canada.
J Paul EkwaruMedlior Health Outcomes Research Ltd., Calgary, AB Canada.
W Tim McGawFaculty of Medicine & Dentistry, Department of Dentistry, University of Alberta, Edmonton, AB Canada.
Kevin E LungKingsway Oral and Maxillofacial Surgery, Edmonton, AB Canada.
Hadi SeikalyFaculty of Medicine & Dentistry, Department of Dentistry, University of Alberta, Edmonton, AB Canada.
Barrie RenickProteocyte Diagnostics Inc., Toronto, ON Canada.
Diana M LinThe University of Alabama at Birmingham, Birmingham, AL USA.
Anthony MorlandtProteocyte Diagnostics Inc., Toronto, ON Canada.
Kenneth H PritzkerProteocyte Diagnostics Inc., Toronto, ON Canada.
Mark R DarlingDepartment of Pathology and Laboratory Medicine, The University of Western Ontario, 1151 Richmond Street, Health Sciences Addition Room 424, London, ON N6A 5C1 Canada.ORCID 0000-0002-5404-2201

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Current management of oral potentially malignant disorders (OPMDs) based on dysplasia grading is controversial. The malignant transformation rate of OPMDs does not correlate well with dysplasia grading, resulting in non-standardized treatment for patients. A quantitative biomarker-based risk score (qBRS; trade name StraticyteTM) was previously developed to address shortcomings related to the current standard of care. A multicenter, retrospective cohort study consisting of biopsied OPMDs was used to validate qBRS for predicting transformation of OPMDs to OSCC. Materials & Methods: Three hundred and two cases were immunostained, imaged, and analyzed via qBRS. A binary prognostic risk was determined using a receiver operating characteristic curve optimizing sensitivity and specificity. Kaplan-Meier analysis was used to estimate the cumulative probability of lack of malignant transformation for patients with elevated or normal biomarker-based risk. Results: The results demonstrated very high sensitivity (96.2%) and negative predictive value (96.2%) for qBRS. Elevated risk scores had higher predicted probabilities of transformation to cancer, independent of dysplasia grade. Conclusions: qBRS can be a useful clinical adjunct tool to dysplasia grading for the assessment of malignant transformation potential, providing a quantitative metric in OPMDs. The addition of qBRS to current histological techniques should improve early detection rates of OSCC, enhancing the effectiveness of treatment.

Indexed as

LeukoplakiaOral cancer riskOral epithelial dysplasiaOral potentially malignant disorderPotentially premalignant oral epithelial lesionStraticyte

Identifiers

PMID41054469
PMCPMC12496382

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.