SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01587573

Developed by Shray Alag, 2019.
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 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1
Squamous cell carcinoma
Genes 62
BLM TYR CDKN2A NUTM1 TGFBR2 KRT5 COL7A1 GTF2E2 GJB2 ERCC2 KRT14 ERCC3 CIB1 ERCC4 ERCC5 WWOX LMNA SASH1 RNF6 TINF2 ING1 SLC17A9 DOCK8 LZTS1 PSENEN FDPS NTHL1 CTSC GJB6 BRD4 POLH RECQL4 RNF113A TMC6 FERMT1 MC1R WRN TMC8 LAMA3 MPLKIP GTF2H5 WNT10A DKC1 LAMB3 NLRP1 LAMC2 SLC45A2 OCA2 XPC MMP1 TNFRSF10B DCC WRAP53 TERC TERT RSPO1 DDB2 SLX4 STAT1 MVD IL7 MVK