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Leukoplakia, Oral clinical trials

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NCT ID: NCT06321003 Recruiting - Oral Cancer Clinical Trials

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

SYMILIS OCT
Start date: March 13, 2024
Phase:
Study type: Observational

This clinical trial aims to assess the efficacy of Optical Coherence Tomography (OCT) in the early diagnosis of oral cancer. It focuses on Oral Potentially Malignant Disorders (OPMDs) as precursors to Oral Squamous Cell Carcinoma (OSCC). Despite the availability of oral screening, diagnostic delays persist, underscoring the importance of exploring non-invasive methodologies. The OCT technology provides cross-sectional analysis of biological tissues, enabling a detailed evaluation of ultrastructural oral mucosal features. The trial aims to compare OCT preliminary evaluation with traditional histology, considered the gold standard in oral lesion diagnosing. It seeks to create a database of pathological OCT data, facilitating the non invasive identification of carcinogenic processes. The goal is to develop a diagnostic algorithm based on OCT, enhancing its ability to detect characteristic patterns such as the keratinized layer, squamous epithelium, basement membrane, and lamina propria in oral tissues affected by OPMDs and OSCC. Furthermore, the trial aims to implement Artificial Intelligence (AI) in OCT image analysis. The use of machine learning algorithms could contribute to a faster and more accurate assessment of images, aiding in early diagnosis. The trial aims to standardize the comparison between in vivo OCT images and histological analysis, adopting a site-specific approach in biopsies to improve correspondence between data collected by both methods. In summary, the trial not only evaluates OCT as a diagnostic tool but also aims to integrate AI to develop a standardized approach that enhances the accuracy of oral cancer diagnosis, providing a significant contribution to clinical practice.

NCT ID: NCT06256809 Not yet recruiting - Oral Leukoplakia Clinical Trials

Analyzing Handprint Patterns to Predict Oral Cancer Risks: A Comparative Study

QQA-FPD-PMML
Start date: February 29, 2024
Phase:
Study type: Observational [Patient Registry]

Aims: To evaluate the qualitative and quantitative parameters of finger and palmar dermatoglyphic patterns in patients with oral premalignant and malignant lesions OBJECTIVES: 1. To record and study the palmar and fingerprint patterns in patients with oral premalignant and malignant lesions 2. To assess the variations in patterns of dermatoglyphic features between cases and controls and to observe the significant result. 3. To evaluate which dermatoglyphic pattern is predominant among patients with premalignant and malignant lesions. Materials and METHODS: Fingerprints and palm prints were studied in 160 patients, who were randomly divided into four groups: A. 40 patients with a history of areca nut /tobacco intake with the occurrence of the premalignant lesion (B) 40 patients with a history of areca nut /tobacco intake with the occurrence of Oral Squamous Cell Carcinoma. (C) As healthy controls, 40 patients with tobacco/areca nut chewing habits, without any evidence of oral lesions (D) 40 patients without any habit, and without any oral lesions. Dermatoglyphic patterns were recorded and analyzed in the four groups using the standard ink method.

NCT ID: NCT05942794 Recruiting - Oral Cancer Clinical Trials

Identification of Oral Lesions Through an Autofluorescence System

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.

NCT ID: NCT05730855 Completed - Oral Lichen Planus Clinical Trials

Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions

Start date: November 1, 2022
Phase:
Study type: Observational

The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.

NCT ID: NCT05727761 Not yet recruiting - Oral Leukoplakia Clinical Trials

Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

Start date: June 15, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in > 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.

NCT ID: NCT05505539 Withdrawn - Oral Leukoplakia Clinical Trials

Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia

OL_5FU
Start date: September 30, 2022
Phase: Phase 1
Study type: Interventional

This is a single center, open-label, interventional pilot study to assess the feasibility, safety, and preliminary efficacy of intralesional 5-FU injections for the treatment of oral leukoplakia (OL).

NCT ID: NCT05237960 Recruiting - Oral Leukoplakia Clinical Trials

Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia

Start date: January 12, 2023
Phase: Phase 2
Study type: Interventional

This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.

NCT ID: NCT04858100 Recruiting - Leukoplakia, Oral Clinical Trials

Oral Potentially Malignant Disorders: Comparison Between Surgical Treatment and Wait and See Approach

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This research protocol is comparing the effectiveness of surgical excision to the "wait and see" approach for the management of oral leukoplakia and erythroleukoplakia in prevention of oral squamous cell carcinoma onset.

NCT ID: NCT04732741 Not yet recruiting - Oral Cancer Clinical Trials

Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions

Start date: March 10, 2021
Phase:
Study type: Observational

Synucleins are a family of small, highly conserved proteins found in vertebrates and are specially abundant in neurons particularly in presynaptic terminals (Surguchov et al., 2001). Gamma-synuclein is the third member of the synuclein family, and is predominantly found in the cytosol of tumor cells and functions both intra- and extra-cellularly. It is involved in the pathogenesis of different types of cancer and some neurodegenerative diseases (Liu et al., 2018). Smoking - a major risk factor for oral cancer and its progression - and nicotine-containing products were found to time-dependently up-regulate the Gamma-synuclein expression in cancer cells (Hsu et al., 2020a). Gamma-synuclein is released from tumor cells and was found to be elevated in tumors such as urinary bladder cancer (Liu et al., 2016), colorectal cancer, gastric adenocarcinomas and esophageal cancer (Liu et al., 2012). It is present in blood, serum, cerebrospinal fluid and saliva. The detection of extracellular synucleins in body fluids can reveal the first steps of the disease thus it can be used as a potential tool for early cancer detection (Surguchov, 2016). This study aims to identify the diagnostic accuracy of Gamma-synuclein in differentiating between oral malignant lesions and oral premalignant lesions.

NCT ID: NCT04712929 Completed - Oral Leukoplakia Clinical Trials

Candida Associated Cytokines in Oral Leukoplakia

Start date: November 1, 2018
Phase:
Study type: Observational

This study aims to determine the correlation between candida and pro- inflammatory cytokines response in Oral Leukoplakia(OL) with antifungal therapy. Ethical clearance from the Institutes ethical committee and Informed written consent from the patient will be obtained. The study group would comprise of clinically and histopathologically confirmed cases of OL (60 patients). The control group would be 30 dental patients ( age & sex matched) who do not any malignancy, OL or any other potentially malignant disorder of oral mucosa. Patients who have any predisposing factor for oral candidiasis will be excluded from the study. Swabs will be taken from the oral lesion and cultured for candida to determine phenotypes, virulence attributes and antifungal sensitivity. Sterile PVA opthalmic sponges will be used to collect sample from the surface of oral epithelium and then processed to determine levels of pro- inflammatory cytokines (IL-6, IL-8. IL-17, TNFα). This procedure will be repeated in study group 2 weeks after a course of antifungal therapy. The results will be tested statistically at a confidence level of 95%.