Clinical Research Directory

FENDRR and CRNDE With DUSP1 and DMBT1 in Oral Leukoplakia and Oral Squamous Cell Carcinoma

Sponsor: Amina Fouad Farag

Summary

Oral squamous cell carcinoma (OSCC) is the most common cancer of the mouth and is often preceded by oral leukoplakia (OL), a white patch of the oral lining that can turn into cancer. At present it is difficult to predict which leukoplakias will become malignant, and OSCC is frequently diagnosed at a late stage. Long non-coding RNAs (lncRNAs) are RNA molecules that do not produce proteins but regulate genes and cell-signalling pathways, and they are being studied as markers of cancer. This prospective diagnostic and prognostic accuracy study examines whether two lncRNAs, FENDRR and CRNDE, and two proteins, DUSP1 and DMBT1, can distinguish OL and OSCC from normal oral tissue and from each other, and whether they predict the course of the disease. Their performance is compared with markers of the PI3K/AKT/mTOR and ERK signalling pathways (PI3K, AKT, mTOR, ERK2 and MMP9), which are commonly activated in oral cancer. Tissue is obtained from patients undergoing surgical removal of OL, OSCC, and from healthy volunteers undergoing routine minor gingival surgery (control group). No additional procedure is performed for the purpose of the study. The diagnosis and grade of each lesion are confirmed by two oral pathologists who are unaware of the laboratory results. FENDRR, CRNDE, PI3K, AKT and mTOR are measured by real-time RT-PCR, and DUSP1, DMBT1, ERK2 and MMP9 by ELISA. The primary outcome is the diagnostic accuracy (area under the ROC curve, sensitivity and specificity) of each marker for OL versus controls, OSCC versus controls and OSCC versus OL. Secondary outcomes are the association of marker expression with clinicopathological features (histological grade, clinical stage, degree of invasion, invasive front, lymph node and distant metastasis, and malignant transformation of OL) and with disease-free and overall survival during 24 months of follow-up. The study hypothesis is that low FENDRR, DUSP1 and DMBT1 and high CRNDE expression accompany progression from normal mucosa to OL and OSCC and are associated with a poorer outcome, so that these markers could support early diagnosis and risk assessment of oral potentially malignant and malignant lesions.

Official title: Diagnostic and Prognostic Role of FENDRR and CRNDE With DUSP1 and DMBT1 in Oral Leukoplakia and Oral Squamous Cell Carcinoma

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