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Oral Epithelial Dysplasia clinical trials

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NCT ID: NCT04153266 Completed - Quality of Life Clinical Trials

Oral Epithelial Dysplasia Informational Needs Questionnaire

ODIN-Q
Start date: October 31, 2018
Phase:
Study type: Observational

Background: Oral epithelial dysplasia (OED) is a condition with an increased risk of oral cancer. Due to the current changes in the factors associated with these diseases (because of human papillomavirus), it is expected that those who have no history of smoking or alcohol, young (<50 years old), and white male would be commonly affected. Those individuals require a higher need for information, preferred a more active role in decision-making, and have a longer lifespan than older individuals. There remain no detailed studies of whether the informational needs delivered to patients with OED met their needs or indeed what information such patient may wish. A few tools are available to evaluate the IN of patients with head and neck disorders. However, the items of these instruments were dedicated to a particular disease (e.g. cancer) and hence are not applicable to be used for OED. Project aims: To evaluate the psychometric properties of the Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for the proposed study, in a cohort of patients with OED. Timescale: 19 months. Clinical significance: This questionnaire can be useful in clinical practice. It could help to meet the patient's information needs and plan educational interventions for those showing unmet needs.

NCT ID: NCT03418454 Recruiting - Clinical trials for Oral Squamous Cell Carcinoma

The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw

Start date: December 14, 2017
Phase:
Study type: Observational

Oral squamous cell carcinoma (OSCC) is the most common malignant tumor of the head and neck, and its incidence has increased in recent years. Extensive surgery with neck dissection and chemo/radio/ targeted therapy is the current treatment for OSCC, and despite great progress in chemotherapy, radiotherapy, and targeted therapy in the last three decades, the prognosis of OSCC is still poor due to aggressive local invasion and metastasis, which lead to recurrence. Postoperative tumor recurrence confers a poor prognosis in OSCC and a poor quality of life. The 5-year survival rate is over 90% in OSCC patients without recurrence and 30% in patients with recurrence, with a median survival of 76.8 months in patients without recurrence and 42.5 months in patients with recurrence . Therefore, it is important to identify biomarkers that may predict the postoperative recurrence of OSCC. Also, some of the OSCC are preceded by precursor lesions. In the oral cavity the most common lesions recognized as potentially malignant are leukoplakia and erythroplakia, but it is also apparent that as many as 50% of OSCC arise from apparently clinically normal mucosa. The prognostic significance of an individual lesion is difficult to determine. At present therefore, the gold standard for the assessment of oral potentially malignant lesions is microscopic evaluation of haematoxylin and eosin stained sections for the presence of architectural and cytological changes, which are generally referred to as oral epithelial dysplasia (OED). The human microbiome is defined as the collective genomes of the microbes (composed of bacteria, bacteriophages, fungi, protozoa and viruses) that live inside and on the human body, and there are approximately 10 microbes and 100 microbial genes for each human cell and gene respectively. With the advent of next generation sequencing technology, the Human Microbiome Project delineated the composition of healthy microbial communities associated to different body sites in healthy individuals, including the oral cavity [Human microbiome consortium]. As opposed to a normal (healthy) microbiome, a disrupted microbiome or dysbiosis represents the lack of equilibrium, and is hypothetically related to disease. Interestingly, the healthy oral microbiome shows relative intraindividual stability over time, suggesting that differences in microbiome profiles may serve as useful tools for the identification of disease states. The working hypothesis is that in OSCC patients, the oral microbiome is altered in comparison to healthy individuals and certain microbial signatures are characteristic of healthy versus disease. In addition, in precursor conditions, i.e., oral epithelial dysplasia (OED), a partial alteration in the composition of the microbiome may predict the progression to malignancy.Also, during treatment, it could be that specific microbial signatures are associated with incomplete eradication, tendency to local recurrence or metastatic potential.Correlations to local recurrence (LR), distant metastases (DM) or disease free survival (DFS) adjusted to clinicopathologic correlations will be sought. In this study, buccal mucosa samples will be collected from patients with OSCC, OED and from healthy individuals , after signing for informed consent, according to Helsinki protocol. Routine pathologic diagnosis will be performed by expert Pathology physicians in our center. Data will be correlated to demographic and clinical data obtained from medical records. This will be carried out in line with institutional ethical guidelines.

NCT ID: NCT02967120 Recruiting - Clinical trials for Oral Epithelial Dysplasia

Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation

Start date: January 2014
Phase: N/A
Study type: Observational

The purpose of this study is to verify the function of p16 hydroxymethylation diagnostic reagents in early diagnosis of oral cancer.

NCT ID: NCT01987934 Enrolling by invitation - Clinical trials for Oral Squamous Cell Carcinoma

Comparison of Morphometric Assessment Using Methyl Green Pyronin and AgNOR Staining of Oral Squamous Cell Carcinoma

OSCC
Start date: June 2013
Phase: N/A
Study type: Observational [Patient Registry]

Oral cancer represents the sixth most common cancer worldwide whilst in Pakistan it ranks the second most common cancer in either gender. Histologically, over 90% of oral cancer lesions are squamous cell carcinomas which are diagnosed on the basis of histopathological analysis. However, proliferation kinetics and nucleolar status are not clearly delineated by routine H&E examination; thus making use of various proliferation markers imperative for the purpose. Nuclear organizer regions (AgNORs) are associated with proliferative activity and represents as a diagnostic aid in oral malignancies. Similarly, methyl green pyronin (MGP) stain has also been valuable as a complement in routine histopathological studies of several neoplastic entities. Morphometric techniques offer an opportunity to quantify nuclear changes associated with malignancy and may provide an objective basis for grading the tumors. The present study is planned to analyze the morphometric parameters of the MGP stain in oral squamous cell carcinoma, and in their various histological grades, and to assess if the MGP staining parameters could give information on the aggressiveness of the malignant lesions of oral cavity. Sections from thirty cases of squamous cell carcinoma along with thirty cases of normal oral mucosa will be evaluated for methyl green pyronin (MGP) and AgNOR staining. Morphometric analysis of various MGP staining and AgNOR parameters would be performed using micrometer. Statistical analysis of the results will be carried out using SPSS. Quantitative variables will be expressed as mean ± Standard Deviation. Frequencies and percentages will be given for qualitative variables. It is hypothesized that oral squamous cell carcinoma will exhibit significantly higher MGP staining and AgNOR staining parameters than normal mucosa of the oral cavity.