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Report for Clinical Trial NCT01587573

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT01587573 Oral Squamous Cell Carcinoma
MeSH:Carcinoma Carcinoma, Squamous Cell
HPO:Carcinoma Squamous cell carcinoma

1 Interventions

Name: saliva collection prior to clinically driven oral biopsy

Description: cell free saliva to be used to measure mRNA and proteins by PCR and ELISA
Type: Other
Group Labels: 1

oral lesions

Primary Outcomes

Description: Based on multimarker test score

Measure: Test specificity at 90% sensitivity

Time: at study completion as well as after model development following enrollment of the first 30 patents with cancer

Secondary Outcomes

Description: Based on comparison of cancer and controls

Measure: Validation of individual mRNA and protein markers

Time: After enrollment of 30 patients with cancer

Description: Based on combined sensitivity and specificity

Measure: Validation of a pre-specified multi marker model

Time: After enrollment of 30 patients with cancer

Time Perspective: Prospective


There is one SNP


1 S100P

Six pre-specified mRNA markers (IL1b, IL8, SAT, DUSP1, OAZ1 and S100P) are measured by polymerase chain reaction. --- S100P ---

HPO Nodes