Developing an In-vitro Diagnostic Risk-Stratification Test for Oral Cancer

Study Overview
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Brief Summary
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The purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.

Detailed Description
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Saliva samples are collected from patients before clinically driven oral biopsy for lesions suspicious for cancer. Specimens are processed by laboratory personnel blinded to the tissue diagnosis. Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are measured by polymerase chain reaction. Markers are compared in cancer and control by raw Ct values as well as by delta Ct after adjustment for housekeeping gens. Appropriate housekeeping genes are identified in a random subset of cancer and control patients and then verified in the remaining subjects. Predictive models are generated by a pre-specified method and robustness evaluated by bootstrap analysis. The model is then further validated in a second cohort. Three pre-specified protein markers (IL8, IL1B, and M2BP) are a secondary endpoint and will also be compared in cancer and control patients.

Official Title
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Pivotal Validation Study of Salivary Biomarkers for the Risk Stratification of Patients With Lesions Suspicious for Oral Squamous Cell Carcinoma

Conditions
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Oral Squamous Cell Carcinoma

Intervention / Treatment
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* Other: saliva collection prior to clinically driven oral biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell cancer Exclusion Criteria: Patients with known prior oral malignancy in last 2 years or other cancer in last 5 years other than non melanoma skin cancer or with immune deficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| oral lesions<br>oral lesions suspicious for squamous cell carcinoma with saliva collection prior to clinically driven oral biopsy | Other: saliva collection prior to clinically driven oral biopsy<br>* cell free saliva to be used to measure mRNA and proteins by PCR and ELISA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test specificity at 90% sensitivity | Based on multimarker test score | at study completion as well as after model development following enrollment of the first 30 patents with cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of individual mRNA and protein markers | Based on comparison of cancer and controls | After enrollment of 30 patients with cancer | 
| Validation of a pre-specified multi marker model | Based on combined sensitivity and specificity | After enrollment of 30 patients with cancer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salivary biomarkers