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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01587573
Study type	Observational
Source	PeriRx
Contact
Status	Recruiting
Phase
Start date	April 2012
Completion date	December 2018

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