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Mouth Neoplasms clinical trials

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NCT ID: NCT06031337 Recruiting - Oral Cancer Clinical Trials

Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study

Start date: September 3, 2023
Phase:
Study type: Observational [Patient Registry]

The study will include patients with oral cancer and healthy controls of both sexes. Subjects having any systemic diseases or other types of cancer will be excluded. All subjects will be selected from Oral Medicine Department, Faculty of Dentistry, Al Ahram Canadian University and Fayoum University. Informed consent will be obtained from all subjects enrolled in this study after explanation of the whole procedure.

NCT ID: NCT05980702 Recruiting - Oral Cancer Clinical Trials

4 Courses vs 2 Courses of Pembrolizumab Combined With Carboplatin and Albumin-binding Paclitaxel of Neoadjuvant Therapy in HNSCC

HNC-SYSU-002
Start date: April 4, 2023
Phase: Phase 2
Study type: Interventional

In this study, 200 patients with resectable head and neck squamous cell carcinoma (T3 or T4, N0) were enrolled and preoperatively combined with pembrolizumab (PD-1 inhibitor), carboplatin, and albumin-binding paclitaxel. The subjects were randomly divided 1:1 into four treatments and two treatments. The imaging and pathological changes of tumor and paracancer tissues before and after treatment were observed. Clinical information, such as pathological grade, stage, treatment, prognosis, serology, imaging, etc., was collected to evaluate the safety and efficacy of 4-course pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with 2-course neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma. This is a prospective, one-arm, phase II clinical study. Main purpose By calculating pathological complete response (pCR) in the experimental group, we evaluated the efficacy (optimality) of four courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with two courses of neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma (T3 or T4, N0). At the same time, this study evaluated the safety of medication, specifically: The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE (version 5.0) during this study and during follow-up, and the occurrence of adverse events in the experimental and control groups will be compared. To evaluate the safety of 4-course Pembrolizumab combined with carboplatin and albumin-binding paclitaxel compared with 2-course neoadjuvant therapy for resectable oral and oropharyngeal squamous cell carcinoma (T3 or T4, N0). Secondary Purpose 1. The event-free survival (EFS) of the two groups were compared; 2. The main pathological response rate (MPR) of the two groups were compared; 3. pTR of the two groups was compared; 4. Overall survival (OS) of the two groups was compared; 5. The radiological responses of the two groups were compared; 6. The operation delay rate of the two groups was compared; Exploratory purpose For the response of enrolled patients after treatment, group treatment was conducted according to the guidelines, and stratified factors influencing the prognosis and treatment plan of immunotherapy were explored according to stratification. The stratification factors taken into consideration are: P16 status, smoking history, TNM stage, tumor reduction (MPR condition), presence of risk factors (according to the guidelines, risk factors are presence of episopercular invasion, positive incisal margin, proximal incisal margin, pT3 or pT4, pN2 or pN3 lymph nodes located in the IV and V regions of the neck, Nerve invasion, vascular invasion, etc.). The purpose of this study was to stratified risk factors for evaluating the efficacy of pembrolizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma. At the same time, hematological, pathological and fecal indicators collected in the design of the experiment were collected. Correlation analysis was conducted to statistically analyze the relationship between these indicators and the therapeutic effect of the program.

NCT ID: NCT05970471 Not yet recruiting - Cancer Clinical Trials

Preferences of Patients Treated With Oral Cancer Drugs and Informal Caregivers for Pharmaceutical Consultation in Hospital

IMPLICATION
Start date: September 1, 2023
Phase:
Study type: Observational

To ensure the safe use of oral anticancer drugs, oncology pharmacy consultations (OPCs) have been established in France. Their goal is to provide the patient with the means to identify, prevent and limit adverse effects and to know who to refer to in case of a serious adverse effect, perform a pharmaceutical analysis of the prescription, and participate in the improvement and evaluation of overall compliance. OPCs are conditioned by the needs, expectations, and involvement of the patients in their care. In healthcare, patients are increasingly encouraged to play an active role in the knowledge and management of their health, express their concerns and preferences, and participate in medical decisions. Thus, it is essential to elicit their preferences. The discrete-choice experiment (DCE) is the validated and recommended method of the International Society for Pharmacoeconomics and Outcomes Research for such a task.

NCT ID: NCT05969314 Active, not recruiting - Breast Cancer Clinical Trials

To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer

Start date: June 8, 2022
Phase: Phase 1
Study type: Interventional

Phase 1 study to assess the pharmacokinetic availability and safety and tolerability profile of one such ayurvedic preparation which contains 5 mg THC:CBD 1:1 preparation. Other than the PK profile, we will also be studying its effect on gene expression profiling of the breast and head neck oral cavity squamous cell carcinoma tissue.

NCT ID: NCT05950737 Recruiting - Clinical trials for Oral Cavity Squamous Cell Carcinoma

Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Sentinel node biopsy is a suitable alternative to END and is recommended in standard guidelines. Investigators have been doing SNB in their department to standardize the process for the last two years. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at their institute.

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: NCT05941338 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCC

HNC-SYSU-001
Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

In this study, 100 patients with resectable head and neck squamous cell carcinoma (oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma) were enrolled, who were combined with tirelizumab, carboplatin and albumin-binding paclitaxel before and after surgery. Tumor tissues and paracancer tissues of patients were collected to observe the imaging and pathological changes before and after treatment. At the same time, clinical information of patients, such as pathological grade, stage, treatment, prognosis, serology, imaging, etc. were collected to evaluate the safety and feasibility of tirelizumab combined with carboplatin and albumin-binding paclitaxel for neoadjuvant therapy of resectable oral and oropharyngeal squamous cell carcinoma. This is a prospective, one-arm, phase II clinical study. Purpose Main purpose The efficacy of Tirelizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma was evaluated by calculating the major pathological response (MPR) rates in the experimental group. The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE (version 5.0) during the course of this study and during follow-up, the incidence of adverse events in the experimental and control groups will be compared, and the safety of neoadjuvant therapy with Tirelizumab combined with carboplatin and albumin-paclitaxel in resectable head and neck squamous cell carcinoma will be evaluated. Secondary Purpose 1. One-year event survival rate and event-free survival (EFS) of enrolled patients were evaluated (five years); 2. Pathological complete response rate (pCR) of enrolled patients was evaluated (5 years); 3. pTR of enrolled patients was evaluated; 4. Overall survival (OS) of enrolled patients was evaluated (5 years); 5. Radiological response of enrolled patients was assessed; 6. The rate of operation delay of enrolled patients was evaluated;

NCT ID: NCT05927220 Recruiting - Oral Cancer Clinical Trials

WORST PATTERN OF INVASION IN ORAL SQUAMOUS CELL CARCINOMA

Start date: July 3, 2023
Phase:
Study type: Observational

Cancer of the oral mucosa, also known as oral squamous cell carcinoma (OSCC), occurs as an ulceroproliferative lesion that can develop at any site in the mouth, from the lips to oropharynx. OSCC (Oral squamous cell carcinoma) is a biologically aggressive tumor and this has piqued interest in research into several prognostic histopathological indicators during the past few decades. The AJCC 8th edition TNM staging system incorporates histopathological factors including depth of invasion (DOI) that affect patient outcomes. Numerous studies have linked a poor prognosis and increased locoregional failure with certain "patterns of invasion" (POI) in OSCC. However, this factor is not utilized for treatment decision making and for outcome assessment. The management and prognosis of oral squamous cell carcinoma (OSCC) depends on tumor stage, differentiation, perineural and lymphovascular invasion, depth of invasion, margin status, lymph node (LN) metastasis and extranodal extension. We will evaluate the relationship of these histopathological parameters with cohesive and non cohesive worst patterns of invasion (WPOI) in OSCC. The purpose of this cross-sectional study is to determine that presence of non-cohesive WPOI is associated with advanced T stage, poor differentiation, PNI, greater depth of invasion, and higher chances of nodal metastasis. WPOI is associated with poor DFS (disease free survival), treatment intensification in early stage disease with non-cohesive WPOI may improve survival. Therefore, it should also be included in routine reporting protocol for OSCC to aid in describing the aggressive behaviour of disease.

NCT ID: NCT05876247 Recruiting - Clinical trials for Oral Cavity Squamous Cell Carcinoma

Articulatory Adaptation Following Oral Cancer Treatment

SPOKE
Start date: November 10, 2022
Phase:
Study type: Observational

The goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. The main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual differences in the reliance on auditory or tactile information can predict the success of speech compensatory strategies. Participants will perform multiple speech tasks while motion tracking sensors track the articulatory gestures.

NCT ID: NCT05865548 Recruiting - Oral Cancer Clinical Trials

Addition of Aspirin to Standard of Care in Oral Cancer

Start date: May 17, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Despite accumulating evidence of the benefit of aspirin in cancer, its effect on improving cancer survival is still debated since the mechanism by which it impacts cancer survival is not completely understood and the published data are discordant. There have been 4 randomized controlled trials (RCT) showing mixed results from no effect to improved survival. Several retrospective and observational studies have reported a survival advantage of adding aspirin to the treatment for various cancers. A meta-analysis of 118 studies, 63 of them specifically reporting on cancer mortality and the rest on all-cause mortality, found a 21% reduction in cancer deaths and about 20% reduction in all-cause mortality (pooled hazard ratio (HR): 0.79; 95% confidence intervals: 0.73, 0.84). However, the evidence is still lacking and there is need to do more RCT