Oral Squamous Cell Carcinoma
Conditions
Keywords
salivary biomarkers
Brief summary
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
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.
Interventions
OTHERsaliva collection prior to clinically driven oral biopsy
cell free saliva to be used to measure mRNA and proteins by PCR and ELISA
Sponsors
PeriRx
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test specificity at 90% sensitivity | at study completion as well as after model development following enrollment of the first 30 patents with cancer | Based on multimarker test score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of individual mRNA and protein markers | After enrollment of 30 patients with cancer | Based on comparison of cancer and controls |
| Validation of a pre-specified multi marker model | After enrollment of 30 patients with cancer | Based on combined sensitivity and specificity |
Countries
United States
Outcome results
None listed