Oral Leukoplakia (OL)NCT07906795
FENDRR and CRNDE With DUSP1 and DMBT1 in Oral Leukoplakia and Oral Squamous Cell Carcinoma
An observational study of Oral Leukoplakia (OL) and Oral Squamous Cell Carcinoma (OSCC), run by Amina Fouad Farag at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Leukoplakia (OL), Oral Squamous Cell Carcinoma (OSCC)
- Type of treatment
- Pill or oral medicine
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Dec 2021to 29 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- Lesions which macroscopic features suggest provisional diagnosis with oral squamous cell carcinoma (OSCC) and leukoplakia
- Preoperative incisional biopsy revealed cytological features of dysplasia and malignancy.
Who cannot join
- Previous surgical intervention
- All inflammatory, cystic and metastatic lesions -
- Patients received preoperative chemotherapy or radiotherapy
- Autoimmune disease or consumption of drugs may affect salivary flow.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic and Prognostic Role of FENDRR and CRNDE With DUSP1 and DMBT1 in Oral Leukoplakia and Oral Squamous Cell Carcinoma
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.
Read more
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.
- Keywords
- Oral leukoplakia, Oral squamous cell carcinoma, LncRNAs FENDRR, LncRNAs CRNDE, DUSP1, DMBT1
- Medical subject headings
- Leukoplakia, Oral, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OSCC | Oral squamous cell carinoma | |
| OL | Oral leukoplakia | |
| Control | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to August 29, 2023
Secondary outcomes (2)
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.
Measured: 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.
Measured: August 29, 2025 (24 months follow-up after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start26 Dec 2021
- Primary completion29 Aug 2023
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Leukoplakia (OL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amina Fouad Farag
- Sponsor type
- University, hospital or other
- Collaborators
- October 6 University
- Responsible party
- Sponsor-investigator, Amina Fouad Farag, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906795
- Sponsor's protocol ID
- RECO6U/14-2021
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Role of FENDRR and CRNDE With DUSP1 and DMBT1 in Oral Leukoplakia and Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07906795
- Acronym / sponsor ID
- RECO6U/14-2021
- Keywords
- Oral leukoplakia, Oral squamous cell carcinoma, LncRNAs FENDRR, LncRNAs CRNDE, DUSP1, DMBT1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Amina Fouad FaragUniversity, hospital or other
- Collaborators
- October 6 University
- Study start
- 26 Dec 2021 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSCC | – | –Oral squamous cell carinoma |
| OL | – | –Oral leukoplakia |
| Control | – | –Control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (2 listed)
- Lesions which macroscopic features suggest provisional diagnosis with oral squamous cell carcinoma (OSCC) and leukoplakia
- Preoperative incisional biopsy revealed cytological features of dysplasia and malignancy.
Key exclusion criteria (4 listed)
- Previous surgical intervention
- All inflammatory, cystic and metastatic lesions -
- Patients received preoperative chemotherapy or radiotherapy
- Autoimmune disease or consumption of drugs may affect salivary flow.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic potential of FENDRR, CRNDE, DUSP1 and DMBT1
Time frame: From enrollment to August 29, 2023
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.
2 secondary outcomes
Association of biomarker expression with clinicopathological characteristics
Time frame: From enrollment to August 29, 2023
Prognostic significance of biomarker expression for disease-free and overall survival
Time frame: August 29, 2025 (24 months follow-up after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Leukoplakia (OL) and Oral Squamous Cell Carcinoma (OSCC), run by Amina Fouad Farag at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic potential of FENDRR, CRNDE, DUSP1 and DMBT1 (time frame: From enrollment to August 29, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.