Health TrialsbyHealthPanel

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

ConditionOral Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-90
SponsorProteocyte Diagnostics Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population will be selected from community-based Oral \& Maxillofacial Surgery practices in the provinces of Ontario and Alberta, Canada

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard of Care Histopathology

    Procedure/Surgery

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

  • STRATICYTE Assessment

    Procedure/Surgery

    Assessment for risk of progression to oral cancer

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia2 interventions

Trial outcomes

Primary outcomes

1

Malignant Transformation Rate: Dysplasia

Cancer progression rate in patients with oral neoplasia with dysplasia and STRATICYTE Low-Risk or Elevated Risk

Time frame
60 months

Secondary outcomes

1

Malignant Transformation Rate: No Dysplasia

Cancer progression rate in patients with oral neoplasia without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Time frame
60 months
2

Recurrence Rate

Recurrence rate in patients with oral neoplasia with or without dysplasia and STRATICYTE Low-Risk or Elevated-Risk

Time frame
60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Proteocyte Diagnostics Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now