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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 2012
End Date:December 2018

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

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.

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.

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
We found this trial at
5
sites
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East Lansing, MI
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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Warren, Michigan 48092
Principal Investigator: Harvey Zalesin, DDS
Phone: 248-967-7791
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Warren, MI
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Wynnewood, Pennsylvania 19096
Phone: 610-446-6900
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Wynnewood, PA
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