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Oral Cancer clinical trials

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NCT ID: NCT03202810 Recruiting - Oral Cancer Clinical Trials

Innovative Approach to Triage Oral Precancer

iTOP
Start date: November 15, 2011
Phase: N/A
Study type: Observational [Patient Registry]

Oral cancer is a major health problem worldwide, accounting for 274,000 new cases and 145,000 deaths annually. On average, half of the patients die within 5 years of an oral cancer diagnosis. Most troubling, however, is the lack of significant change in prognosis for this disease over the last 4 decades, even in developed nations. Even when successful, treatment of oral cancer can be devastating due to diminished quality of life and disfigurement. The key to controlling this disease is early identification of lesions that are at high risk of progression and provide effective treatment. The overall objective of the team is to integrate clinical, pathological, molecular, and imaging data to create a robust oral cancer risk model to predict the risk of progression of OPLs and to develop population-wide cost-effective prevention strategies for high-risk oral premalignancies. The project will involve 4 specific aims as described in detail below. Aim 1. To use molecular data to stratify low-grade OPLs into high- and low-risk groups. Aim 2. To evaluate the cost-effectiveness of various follow-up frequency that use LOH at chromosome 9p21 as a risk marker. Aim 3: To evaluate the specificity and sensitivity of using imaging technologies as a tool for the decision of the high-grade or high-risk biopsy site. Aim 4. To assess the clinical utility of a miRNA expression signature derived from serum collected from patients with oral cancer and OPLs.

NCT ID: NCT03017053 Recruiting - Oral Cancer Clinical Trials

The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor

Start date: July 2016
Phase: Phase 4
Study type: Interventional

Cervical nodal metastasis is the most certain prognostic factor in oral cancer. Appropriate management of the neck is therefore of paramount importance in the treatment of oral cancer. However, there is still some controversy on the treatment of early maxillofacial malignancies. Currently, investigators have no accurate uniform treatment standards, including the National Comprehensive Cancer Network (NCCN) recommended between surgery and radiotherapy options. Clinical evaluation indicated that lymph node-negative patients eventually 25%-35% had cervical node metastasis. Therefore, for the majority of patients with true node-negative, preventive cervical lymph node dissection is obviously over-treatment, and lower quality of life. Radiotherapy can avoid such surgery.

NCT ID: NCT02960724 Recruiting - Neoplasms Clinical Trials

uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

Start date: November 2016
Phase: Phase 2
Study type: Interventional

uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer

NCT ID: NCT02902406 Recruiting - Oral Cancer Clinical Trials

Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

Start date: April 18, 2016
Phase:
Study type: Observational

This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all subjects will receive an intraoral examination and followed by epithelial cells collection with oral swab. The gDNA will be extracted from the oral swab collected cells and followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.

NCT ID: NCT02866500 Recruiting - Oral Cancer Clinical Trials

Oral State of Patients Affected by an Oral Cancer Before and After Radiotherapy - 3-years Prospective Study

VADS
Start date: January 2015
Phase: N/A
Study type: Interventional

Context: the oral cancer is the 5th cancer in order of frequency for human in France. It is the country where the mortality by oral cancer is the most raised in Europe. The most frequent location concerns the oral cavity prevalency of which is one of higher in the world. The main risk factors are the tobacco and the alcohol. The oral cancer is treated in the great majority of the cases by radiotherapy which is going to pull xerostomy, responsible for the degradation of the oral state. Furthermore, it will increase the risk of appearance of osteoradionecrosis (ORN) when the patient is carrier of buccal lesions and\or when he will have to undergo surgical acts. Consequently, the initial oral state of the patients is to be estimated so as to eliminate any source of the infection. An unfavourable initial state will increase the risk of degradation of this one and appearance of ORN. However, at present few epidemiological data are available concerning the oral state of the patients presenting an oral cancer. Objective: the main objective of this study is to describe, before radiotherapy, the oral state of the patients presenting an oral cancer and to follow the evolution of this oral state for three years and to register the patients quality of life. The secondary objectives are to describe the distribution of risk factors of the degradation of the oral state (oral hygiene, food habits, xerostomy, consumption of tobacco and alcohol) in this population and to register the impact of the dental restorations on the radiological assessment. Methods: this prospective epidemiological study of observation will be realized in the service of odontology of the Timone hospital (Marseille, France) in association with the services of ORL and maxillofacial surgery of Timone as well as the services of radiotherapy and medical oncology of Timone and Paoli Calmettes institute (IPC). All the toothed patients affected by an oral cancer untreated will be included, or treated surgically only, of more than 18 years old and for whom an initial dental assessment will be realized. The main assessment criteria will be the CAD index and the parodontal state. Expected results and perspectives: This study will allow to have epidemiological data concerning patients' oral state affected by an oral cancer before and after radiotherapy. It will allow to set up a consensus of good practice.

NCT ID: NCT02584270 Recruiting - Oral Cancer Clinical Trials

Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue

PGSRT
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality in a robust scientific randomized prospective clinical trial. Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion on their tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing is not routinely provided with the device.

NCT ID: NCT01919580 Recruiting - Oral Cancer Clinical Trials

Study on the Carcinogenesis of Gα12 in Oral Cancer, and the Treatment of Oral Cancer Using Ga12 Inhibitor.

Start date: December 2012
Phase: N/A
Study type: Observational

Study on the carcinogenesis of Gα12 in oral cancer, and chemopreventive possibility for the treatment of oral cancer using Ga12 inhibitor.

NCT ID: NCT01919567 Recruiting - Oral Cancer Clinical Trials

Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.

Start date: November 2011
Phase: N/A
Study type: Observational

Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.

NCT ID: NCT01039298 Recruiting - Oral Cancer Clinical Trials

Efficacy of Optically-guided Surgery in the Management of Early-staged Oral Cancer - COOLS TRIAL

Start date: January 2013
Phase: Phase 3
Study type: Interventional

Oral squamous cell carcinoma (SCC) is a global disease responsible for ~300,000 new cancer cases each year. Local recurrence (~30% of cases) and formation of second primary malignancy are common.2, 3 Cosmetic and/or functional compromise associated with treatment of disease stage is often significant. These statistics underscore the urgent need to develop a better approach in order to control this deadly disease. It is becoming increasingly apparent that oral cancers develop within wide fields of diseased tissue characterized by genetically altered cells that are widespread across the oral cavity and present in clinically and histologically normal oral mucosa. Complete removal of these lesions is difficult because high-risk changes frequently go beyond clinically visible tumor. In recognition of this, current 'best practice' is to remove SCC with a significant width (usually 10 mm) of surrounding normal-looking oral mucosa. However, since occult disease varies in size such approach often results in over-cutting (causing severe cosmetic and functional morbidity) or under removal of disease tissue, as evidenced by frequent positive surgical margins and high local and regional recurrence - a failure of the 'best practice. There is a wealth of literature that supports the use of tissue autofluorescence in the screening and diagnosis of precancers in the lung, uterine cervix, skin and oral cavity. This approach is already in clinical use in the lung and the mechanism of action of tissue autofluorescence has been well described in the cervix. Changes in fluorescence reflect a complex interplay of alterations to fluorophores in the tissue and structural changes in tissue morphology, each associated with progression of the disease. As one of the internationally leading teams in applying tissue fluorescence technology, we have shown that direct fluorescence visualization (FV) tools can identify clinically visible or occult premalignant and malignant lesions that are associated with lesions at risk, with high-grade histology and high-risk molecular change. In a recently small scaled, retrospective study, we have shown that FV helped surgeons in the operating room to determine the extent of the high-risk FV field surrounding the cancer and resulted in remarkably lower 2-year recurrence rates (0% for FV-guided vs. 25% for those without FV-guided approach). There is need to design a larger scale prospective, randomized controlled (Phase III) trial to gather strong evidence in proving the efficacy of the surgery approach using this adjunct tool. To establish the evidence supporting the change in clinical practice using FV-guided surgery. There are 3 objectives. 2.1. Objective 1 (Clinical evidence): To assess the effect of FV-guided surgery on the recurrence-free survival of histologically confirmed disease within the context of a randomized controlled trial (efficacy). Hypothesis: FV-guided surgery will increase the recurrence-free survival. 2.2. Objective 2 (Quality of Life evidence): To establish the cost per recurrence prevented for this approach and assess quality of life issues. Hypothesis: FV-guided surgery can be delivered in a cost effective manner and improve the quality of life of patients 2.3 Objective 3 (Scientific/Molecular evidence): To assess the presence of previously validated molecular markers (microsatellite analysis, LOH) and histological change (quantitative pathology) in surgical margins in a nested case-control study involving a tumor bank created within this project. Hypothesis: FV-guided surgery will spare normal tissue at the same time improving capture of high-risk tissue.

NCT ID: NCT00767442 Recruiting - Oral Cancer Clinical Trials

Least Invasive Nonlinear Light Microscopy

Start date: December 2008
Phase: N/A
Study type: Observational

Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy