Recruiting

Observational Study

Sponsor:

Proteocyte Diagnostics Inc.

Code:

NCT05853783

Conditions

Mouth Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STRATICYTE™ Test

Study Details

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.

Conditions

Mouth Diseases

Study ID

NCT05853783

Start date

Jan 1, 2023

Status verified date

Nov, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Arms

OPMDs that progressed to OSCC

No dysplasia, mild, moderate, severe dysplasia, CIS

OPMDs that did not progress to OSCC

No dysplasia, mild, moderate, severe dysplasia, CIS

Interventions

STRATICYTE™ Test

Assessment for risk of progression to oral cancer

Primary outcome measure

  • Sensitivity and Specificity [ Time Frame: 5 years ]
  • Survival analysis [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jody Filkowski, BSc, MSc, PhD

1-825-305-0749Jody.Filkowski@medlior.com

Jason TK Hwang, HBSc, MSc, PhD

1-647-255-1370jhwang@proteocyte.com

Locations

MD Anderson Cancer Cetner

Recruiting

Houston, Texas, United States, 44907

More Information

Sponsor

Proteocyte Diagnostics Inc.

Last update posted

Nov 7, 2024

Last verified

Nov, 2024

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
  • Personalized medicine
  • Predictive Assay
  • Whole slide imaging
  • Computational pathology
  • Digital pathology
  • Oral potentially malignant lesion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Proteocyte Diagnostics Inc. on 2024-11-07.