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

Brief summary (registry, in English)

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 ribonucleic acids (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 (FOXF1 Adjacent Non-Coding Developmental Regulatory RNA) and CRNDE (Colorectal Neoplasia Differentially Expressed), and two proteins, DUSP1 (Dual Specificity Phosphatase 1) and DMBT1 (Deleted in Malignant Brain Tumors 1), 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 (Phosphoinositide 3-kinase/Protein Kinase/Mechanistic Target of Rapamycin) and ERK (Extracellular Signal-Regulated Kinase) signalling pathways: PI3K, AKT, mTOR, ERK2 and MMP9 (Matrix Metallopeptidase 9), 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 (Reverse Transcription Polymerase Chain Reaction), and DUSP1, DMBT1, ERK2 and MMP9 by ELISA (Enzyme-Linked Immunosorbent Assay). 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.

What you commit to

• Study type: Observational
• Participants enrolled: 62
• From 26 Dec 2021 to the primary completion date, 29 Aug 2023
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.