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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

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

Case-Control


There is one SNP

SNPs


1 S100P

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



HPO Nodes


HPO:
Carcinoma
Genes 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT
Squamous cell carcinoma
Genes 79
COL7A1 WNT10A CDKN2A GJB6 FDPS LZTS1 GTF2H5 TERT NLRP1 ERCC5 NUTM1 ERCC2 RSPO1 LAMA3 TMC8 CTSC ING1 RECQL4 GJB2 ERCC2 TGFBR2 ERCC4 LAMC2 LAMB3 MPLKIP TARS1 ERCC3 XPC DOCK8 BLM NTHL1 TYR PSENEN WRAP53 GTF2E2 IL7 RNF6 SLC17A9 TNFRSF10B DKC1 POLH RECQL4 BLM BRD4 KRT5 TMC6 TERC ERCC2 SASH1 WNT10A MC1R CIB1 SLC45A2 MVD WRN KRT14 DDB2 RNF113A DCC FERMT1 TYR COL7A1 ERCC3 ERCC3 COL7A1 MMP1 COL7A1 GJB2 SLX4 MMP1 LMNA MVK TINF2 WWOX GJB2 OCA2 CIB1 POLH STAT1