Clinical Trial Finder
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment
Study Purpose
The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
Exclusion Criteria:
- Biopsied lesion with or without dysplasia concomitant with oral squamous cell carcinoma at initial biopsyTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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).Arms
: Oral Mucosal Biopsies With or Without Evidence of Epithelial Dysplasia
No evidence of dysplasia Mild dysplasia Moderate dysplasia Severe dysplasia
Interventions
Procedure: - Standard of Care Histopathology
Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer
Procedure: - STRATICYTE Assessment
Assessment for risk of progression to oral cancer
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Kingsway Oral & Maxillofacial Surgery
Edmonton, Alberta, T5M 3Z7
Site Contact
Tim McGaw, DDS, MSc, MD
[email protected]
(647) 255-1370
Status
Recruiting
Address
University of Alberta
Edmonton, Alberta, T6G 1C9
Site Contact
Tim McGaw, DDS, MSc, MD
[email protected]
(647) 255-1370
Status
Recruiting
Address
Western University
London, Ontario, N6A 5C1
Site Contact
Mark Darling, MSc, MChD
[email protected]
(647) 255-1370
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