An observational study in Oral Leukoplakia (OL) and Oral Squamous Cell Carcinoma (OSCC), sponsored by Amina Fouad Farag. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Amina Fouad Farag · Observational
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.
48 studies on the registry are indexed under Leukoplakia, Oral; 11 are open to participants now.
This study's enrollment of 62 is below the median of 97 across 20 observational studies indexed under Leukoplakia, Oral.
Browse Leukoplakia, Oral studies →Amina Fouad Farag is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the Oral and Maxillofacial Surgery Department, and the General Surgery Department, and outpatient clinics between December 2021 and August 2025, together with healthy volunteers. Of 87 individuals assessed for eligibility, 62 were enrolled in three groups:
Control group (n = 8): healthy, non-smoking volunteers with no oral mucosal disease, from whom gingival tissue was obtained during wisdom tooth extraction.
Oral leukoplakia group (n = 22): patients with clinically diagnosed oral leukoplakia confirmed histologically, graded by epithelial dysplasia as low grade (mild-moderate dysplasia) or high grade (severe dysplasia/carcinoma in situ).
Oral squamous cell carcinoma group (n = 32): patients with histologically confirmed oral squamous cell carcinoma, graded as low grade (well to moderately differentiated) or high grade (poorly differentiated).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral squamous cell carinoma
Oral leukoplakia
Control
Diagnostic potential of FENDRR, CRNDE, DUSP1 and DMBT1
Expression of lncRNA-FENDRR and lncRNA-CRNDE (relative expression, 2\^-ΔΔCt, by real-time RT-PCR) and tissue levels of DUSP1 (pg/mg protein) and DMBT1 (ng/mg protein, by ELISA) are measured in each tissue specimen. Diagnostic accuracy is assessed with receiver operating characteristic (ROC) curve analysis: area under the curve (AUC) with 95% confidence interval, and sensitivity and specificity, for oral leukoplakia versus controls, oral squamous cell carcinoma versus controls, and oral squamous cell carcinoma versus oral leukoplakia. Accuracy is compared with PI3K, AKT, mTOR, ERK2 and MMP9 measured in the same specimens.
Time frame: From enrollment to August 29, 2023
Association of biomarker expression with clinicopathological characteristics
Within the oral leukoplakia and oral squamous cell carcinoma groups, patients are classified as having favourable or unfavourable expression of each biomarker at the group median (unfavourable: low FENDRR, high CRNDE, low DUSP1, low DMBT1). Each category is compared with age, sex, lesion site and size, clinical presentation (oral leukoplakia), histopathological grade, clinical stage, degree of invasion, invasive front, lymph node metastasis and distant metastasis (oral squamous cell carcinoma). Results are reported as the number (%) of patients with unfavourable expression in each category, compared with the Fisher exact test.
Time frame: From enrollment to August 29, 2023
Prognostic significance of biomarker expression for disease-free and overall survival
Patients with oral leukoplakia and oral squamous cell carcinoma are followed after surgery. Disease-free survival is the time from surgery to recurrence, or, for oral leukoplakia, recurrence or malignant transformation. Overall survival is the time from surgery to death from the disease. Survival is compared between favourable and unfavourable expression of each biomarker, and of combined FENDRR/CRNDE and DUSP1/DMBT1 profiles, using Kaplan-Meier curves with the log-rank test. Univariate Cox proportional hazards regression gives hazard ratios with 95% confidence intervals.
Time frame: August 29, 2025 (24 months follow-up after surgery)
Plan to share: No — Individual participant data will not be shared publicly, in accordance with the data protection policy of the Research Ethics Committee, Faculty of Dentistry, October 6 University. Aggregate results are available in the published article. De-identified data may be made available by the corresponding author on reasonable request, subject to approval by the Research Ethics Committee.
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Aug 2023, 20 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Amina Fouad Farag