Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Precancerous Conditions

Oral Squamous Cell Carcinoma

fifteen patients with OPMLs (lichen planus, leukoplakia)

fifteen systemically healthy control subjects

Paxillin biomarker

Yasmine Ramadan

This investigation was carried out to analyze and compare the salivary paxillin levels between oral premalignant and malignant lesions (OPMLs), OSCC and the healthy controls in order to assess its potential role as a biomarker of oral cancer aiming for early diagnosis and better prognosis of OSCC.

Methods: Forty-five patients, ranging in age from thirty to seventy-five, were divided into three groups: fifteen patients with OPMLs (lichen planus, leukoplakia), fifteen patients with OSCC, and fifteen controls who were in general well. Paxillin was identified in saliva samples by using an ELISA kit.

The aim of this study is: comparison of salivary paxillin levels in oral premalignant lesions and OSCC to its levels in healthy subjects.

Subjects and Methods Forty-five participants between the ages of 30 and 70 were accepted for this study. They were registered in the outpatient's clinic of Oral Medicine and Periodontology department in Faculty of Dentistry,Cairo university. Three sets of subjects were assigned: fifteen patients with premalignant lesions, fifteen patients with OSCC, and fifteen systemically healthy control subjects. A complete medical history was obtained for each individual using a modified Cornell Medical Index questionnaire. Upon receiving clarification regarding the scope of the inquiry, each participant completed an informed consent form.

Patients with OSCC were clinically diagnosed, and biopsy specimens from the lesions were taken for histology to confirm the diagnosis.

Collection of saliva samples:

Unstimulated Salivary samples were collected once preoperatively before any intervention All participants were asked to refrain from drinking, eating, or chewing gum for at least 60 minutes before sampling. Samples were collected by asking the patient to swallow first, then lean the head forward for 5 minutes and spit the entire saliva into 50-ml sterile centrifuge tubes. After being assembled, all specimens were immediately stored at -20 ºC until tested.

Quantitation of Human Paxillin salivary level:

Saliva was collected from patients and controls. After centrifugation, the supernatant was separated for detection of Paxillin by using the ELISA technique provided by Cloud Clone Corp, Houston, USA, Catalogue Number: E-01184hu. This kit's microtiter plate has been pre-coated with a paxillin-specific antibody. The relevant microtiter plate wells are then treated with a biotin-conjugated antibody specific to paxillin. Then, Avidin conjugated to Horseradish Peroxidase (HRP) is added and incubated in each microplate well. After adding the TMB substrate solution, only the wells containing paxillin, biotin-conjugated antibody, and enzyme-conjugated Avidin will change colour. The enzyme-substrate reaction is stopped by adding a solution of sulphuric acid, and the colour change is measured spectrophotometrically at 450nm 10nm. The samples' optical density (OD) is then compared to the reference curve to determine their paxillin concentration.

Statistical analysis:

Categorical data were given as frequency and percentage values, and Fisher's exact test was used to assess them. Mean and standard deviation (SD) numbers were used to depict numerical data. The Shapiro-Wilk test was used to determine their normalcy. A one-way ANOVA test followed by Tukey's post hoc test was used to analyse normally distributed data (age and Paxillin (ng/mL) levels). ROC curve analysis was done to determine diagnostic accuracy. A z-test was used to compare ROC curves. The significance level was set at p\<0.05 for all tests. R statistical analysis software version 4.3.1 for Windows was used for the statistical analysis \[18\].

Evaluation of the Levels of Salivary Paxillin Oral Premalignant and Malignant Lesions

to detect the levels of salivary paxillin and compare its levels in the three study groups

Olfat Shaker

Cairo University

lecturer of oral medicine

Mouth and Tooth Diseases

Mouth Neoplasms

Lip Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

The photographs will be taken with a smartphone iPhone 14 Pro in a one-year period. Imaging will follow the recommendations regarding intraoral photography in oral mucosal screening set by (Lin et al., 2021).

Personal data and a brief description of the present illness concerning the main complaint will be informed by the patients and recorded in a diagnosis chart of the Oral medicine department Cairo University. Complete intraoral physical examination will be performed by the main investigator under supervision of the main supervisor and the co-supervisor using dental equipment with artificial light.

Diagnosis by mobile phone imaging

Mary F Mikhail, TA

Salsabeel A Afifi, Lecturer

The aim of study is to evaluate the sensitivity and specificity of using mobile phone photographs versus conventional clinical examination as a screening tool for early detection of oral cancer.

Tele-dentistry is a method of providing oral healthcare and dental services through real-time transmission of clinical information using electronic medical records, digital imaging, photography, ICT, and the internet. Oral medicine is a dental specialty that uses tele-dentistry services to manage patients with systemic diseases and comorbidities. However, some oral disorders may have systemic consequences, necessitating additional diagnostic techniques and skilled doctors. Issues such as lack of oral medicine specialists, inexperienced community health workers, and inadequate training for managing complex oral conditions also pose challenges. Delayed diagnosis of oral cancers in underserved communities, poor patient management, high transportation costs, and lengthy waiting lists are some of the challenges faced by patients.

The COVID-19 pandemic has further complicated these issues, causing disruptions in educational programs and access to oral medicine services. Tele-dentistry can facilitate efficient communication between patients and healthcare professionals for various purposes. There is limited research on using tele-dentistry in oral medicine, especially for results like accuracy. Consequently, the present study is designed to evaluate the sensitivity and specificity of using mobile phone images versus conventional clinical examination as a screening tool for early detection of oral cancer.

Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening

to categorize the oral lesions into:

1. Normal variance
2. Reactive or inflammatory lesions
3. Potentially malignant lesions
4. Oral cancer

when to take a decision of referral to a specialist

Resident Doctor in Department of Oral Medicine ,diagnosis and Periodontology , Faculty of Dentistry Fayoum University

Immune System Diseases

Hypersensitivity

participants suffering from oral potentially malignant lesions

participants suffering from diagnosed oral malignant lesions

healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.

measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)

Enzyme Linked Immunosorbent assay (ELISA)

Salsabeel A Mahmoud

Basma A Zakaria

Salsabeel Ali Mahmoud, MD

The study is designed to measure serum and salivary CYFRA21-1 levels using enzyme linked immunosorbent assay (ELISA) in patients with oral malignancy, oral potentially malignant lesions, and control subjects to evaluate the potential of CYFRA21-1 as a diagnostic marker for malignant transformation in potentially malignant oral mucosal lesions.

Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)

diagnostic accuracy in terms of sensitivity and specificity of serum and salivary CYFRA21-1 in differentiating between oral malignancy and oral potential malignant lesions in order to be able to early diagnose malignant changes in oral lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Levels of Salivary Paxillin Oral Premalignant and Malignant Lesions	NCT06154551	Comparison of S...	Paxillin biomar...	30 Years - 70 Years	Cairo University
Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening	NCT06060288	Premalignant Le... Oral Cancer	Diagnosis by mo...	12 Years -	Cairo University
Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)	NCT03686020	Oral Potentiall... Oral Cancer	Enzyme Linked I...	-	Cairo University

Spots Global Cancer Trial Database for oral potentially malignant lesions