NCT01587573

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 370 (estimated)
• Sponsor: PeriRx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Squamous Cell Carcinoma

Interventions

Type	Name	Description
OTHER	saliva collection prior to clinically driven oral biopsy	cell free saliva to be used to measure mRNA and proteins by PCR and ELISA

Timeline

• Start date: 2012-04-01
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2012-04-30
• Last updated: 2018-04-12

Locations

5 sites across 1 country: United States