Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment

Sponsor

Proteocyte Diagnostics Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04622462

Collaborator

(none)

500

Enrollment

Locations

141.7

Anticipated Duration (Months)

166.7

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral lesions.

Condition or Disease	Intervention/Treatment	Phase
Oral Neoplasm	Procedure: Standard of Care Histopathology Procedure: STRATICYTE Assessment

Detailed Description

Background: The standard of care for potentially premalignant oral epithelial lesion (PPOEL) risk assessment for progression to cancer is dysplasia grading by histopathology. With significant overlap between dysplasia grades and high inter- and intra-observer variations, dysplasia grading alone has been shown to be inadequate as a prognostic tool. To investigate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in the early diagnosis of invasive oral cancer, a prospective multi-center observational study was designed with specimens obtained from community-based practices.

Methods: Patients that qualify to enroll in the study will be assessed for both standard of care histopathological assessment for dysplasia grade and STRATICYTE risk assessment, and followed for up to 60 months (from initial biopsy) to determine the outcome of their oral lesion(s).

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 12, 2015

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia	Procedure: Standard of Care Histopathology Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer Other Names: H&E assessment for dysplasia grade Procedure: STRATICYTE Assessment Assessment for risk of progression to oral cancer Other Names: S100A7 Immunohistochemistry Signature-based Assessment

Arm

Intervention/Treatment

Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia

No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia

Procedure: Standard of Care Histopathology

Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer

Other Names:

H&E assessment for dysplasia grade

Procedure: STRATICYTE Assessment

Assessment for risk of progression to oral cancer

Other Names:

S100A7 Immunohistochemistry Signature-based Assessment

Outcome Measures

Primary Outcome Measures

Malignant Transformation Rate: Dysplasia [60 months]
Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk

Secondary Outcome Measures

Malignant Transformation Rate: No Dysplasia [60 months]
Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk
Recurrence Rate [60 months]
Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any clinically suspicious lesion biopsied to rule-out oral epithelial dysplasia/oral squamous cell carcinoma

Exclusion Criteria:

Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kingsway Oral & Maxillofacial Surgery	Edmonton	Alberta	Canada	T5M 3Z7
2	University of Alberta	Edmonton	Alberta	Canada	T6G 1C9
3	Western University	London	Ontario	Canada	N6A 5C1