Clinical Research Directory

Comparison of TLC (Total Leucocyte Count), Neutrophils and Monocytes in Oral Squamous Cell Carcinoma and Pre-malignant Disorders

Oral squamous cell carcinoma is one of the significant public health concerns and the most prevalent malignancies affecting the head and neck region globally. The primary risk factors for this cancer include tobacco usage, alcohol consumption and increasing incidence of human papillomavirus infections (HPV). The incidence of oral squamous carcinoma has been rising among young populations and the prognosis among young and older patients remains a debated issue. However, recent studies(1) found that there is no significant difference in tumor stage or grade based on age and the premalignant disorders represent an early stage in the evolution of cancer that characterized by molecular alterations and clonal expansions that progress to malignancy. This entails that age specifically is not a determining factor in aggressiveness and treatment outcomes of Oral squamous cell carcinoma, emphasizing the need to focus on other factors that influence prognosis of this condition(2). Premalignant disorders may involve detectable molecular alterations in blood cells and tissues, somatic mutations in key genes included DNMT3A and TET2 have been recognized in leukocytes of healthy individuals indicating a risk of future malignancy. There is a growing area of research where a comparison of hematological parameters like Total leukocytes Count (TLC), neutrophils and monocytes in OSCC patients versus those with premalignant disorders. The measurement of these blood markers provides an insight into immune response and systemic inflammation associated with malignancy progression. The evaluation and finding of Total leukocytes count, neutrophils and monocytes offered important and valuable prognostic information and also helped in distinguishing between malignant and premalignant conditions in the population. The monitoring of genetic mutations in blood cells of individuals could provide a non-invasive method to identify individuals at risk and help in better outcomes(3). The leukocyte counts particularly neutrophils, monocytes and total leukocytes count (TLC) have been investigated for cancer progression and patient immune response. Elevated levels of these blood cells have been observed in patients with oral squamous cell carcinoma indicating systemic inflammation and alterations in immune system that are associated with malignancy, whereas in premalignant conditions alterations in these parameters in the patients indicate immune response to cellular changes with key probable to predict malignant transformation. Comparing the levels of these blood counts in oral squamous cell carcinoma patients and those with premalignant lesions provide valuable awareness and insights into immunological, inflammatory processes involved in the early stages of cancer progression(4). There are approximately 3% of all the malignancies affecting around 270,000 people globally in annual rate. A significant amount of proportion of oral squamous cell carcinoma cases develops from premalignant disorders of the oral cavity including leukoplakia and oral submucous fibrosis, which has very high rate of malignant transformation(5). Therefore, hematological parameters would be explored as potential biomarkers for early detection of OSCC and its prognosis. Studies have revealed that quantitative changes in blood biochemistry and hematology occur during tumor initiation and progression, highlighting their potential role as the tumor markers(6). Therefore, despite the advancement of cancer therapy the prognosis of oral squamous cell carcinoma remained poor. This is largely due to the late diagnosis of the condition, however early detection is critical for improving patient outcomes and some recent research revealed various biomarkers and hematological parameters as a potential diagnostic tool and explored that immunological and hematological changes have been observed particularly alterations in total leukocyte count, neutrophils and monocytes and these changes have been investigated as an indicators of cancer progression. This underscores the importance of studying immune and also hematological detailed profiles in Oral squamous cell carcinoma and its precursor lesions(7). The purpose of the study is to assess and compare particular hematological parameters in individuals with premalignant conditions and those with squamous cell carcinoma. The study focus on hematological profile specifically Total leukocyte count (TLC), neutrophil count and monocyte count. By comparing these hematological markers in the patients with oral squamous cell carcinoma and the patients with pre-malignant lesions, therefore this study seeks to identify a distinct pattern that distinguishes between malignant and premalignant conditions. This comparative study aims to understand immune and inflammatory profiles of patients between two groups of study participants.

Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.

Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants

This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.

Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer

This clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. All tissue and cells are made of tiny particles. Some of these particles give off small amounts of light. This light is called fluorescence. Fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. Fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. Checking mouth tissue samples under a microscope may also help detect abnormal cells. Diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.

Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions

To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions

Application of Artificial Intelligence on the Diagnosis of Helicobacter Pylori Infection and Premalignant Gastric Lesion

The aim of this study is to evaluate the impact of artificial intelligence (AI) assistance during routine upper endoscopy on gastric cancer-specific mortality. We hypothesize that AI-assisted endoscopic interpretation can further reduce gastric cancer-related mortality through two mechanisms: (1) improved detection of H. pylori infection, facilitating timely eradication therapy and subsequent prevention of gastric carcinogenesis; and (2) earlier identification of premalignant gastric conditions, enabling appropriate surveillance endoscopy and earlier detection of gastric cancer. The primary endpoint is gastric cancer-specific mortality.

AI-Based Risk Prediction Model for Upper Digestive Tract Cancer

Upper digestive tract cancers are often preceded by pre-malignant lesions, but there is limited evidence regarding optimal risk prediction models and screening strategies for disease progression and cancer development. This prospective multicenter cohort study aims to establish a longitudinal database integrating clinical information, endoscopic findings, pathology, genetics, epigenetics, and gastrointestinal microbiota data from subjects undergoing upper digestive tract endoscopy. The study will develop explainable artificial intelligence (AI)-based risk prediction models to identify factors associated with disease progression, treatment response, and cancer development. Participants will be followed longitudinally to evaluate changes in lesion severity and clinical outcomes.

Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions

Background: Anastomotic leakage (AL) after colorectal surgery remains a significant challenge, associated with increased morbidity, mortality, poor oncological outcomes, and reduced quality of life. Despite surgical advances, AL rates for colorectal procedures continue to range from 3% to 25%, especially in distal anastomoses. The commonly used cross-stapled circular anastomosis for anterior resections (AR) activates a foreign body response delaying gastrointestinal wound healing and potentially increasing the risk of AL. Additionally, crossed stapler lines further increase the risk of AL. An adaptive anastomosis technique eliminates permanent foreign body material, thereby reducing negative effects on wound healing and avoiding cross-stapling potentially lowering the incidence of AL. These areas have shown to have a lower burst pressure compared to a single stapled anastomosis. An adaptive anastomotic technique eliminates cross-stapling and permanent foreign body material in the anastomosis reducing the negative effects on wound healing potentially lowering the incidence of AL. Design: This is a prospective, international, non-randomized, multicentre study. Endpoints: The Primary objective of this trial is to assess the incidence of AL within 30 days after surgery. Secondary objectives are to assess anastomotic integrity at 90 days and 1 year, intraoperative efficacy and efficiency of the C-REX device, time to evacuation of the anastomotic ring, mode of evacuation and related patient experience, postoperative morbidity and readmissions, C-reactive protein (CRP) profile in the early postoperative period, functional outcomes, cost-effectiveness and surgical quality. Population: A total of 165 patients (age ≥ 18 years) with histologically proven cT1-4aN0-2M0 cancer of the sigmoid colon or proximal rectum, or premalignant lesions not amenable to endoscopic resection, that require elective AR will be enrolled throughout 10 European colorectal centers. Study procedures: The anastomosis will be created using the C-REX RectoAid Cath. The healing period will be approximately 10 days. The anastomotic ring detaches via necrosis and is evacuated with the feces. Patients will be asked to fill out questionnaires regarding Low Anterior Resection Syndrome (LARS) and use of healthcare and these will be gathered preoperatively, 90 days postoperative and 1 year after surgery. At 12 months a CT-scan and colonoscopy will be performed.

Candonilimab and ATRA Acid for Prevention of Oral Cancer Recurrence in Patients With OPL

The aim of this study is to involve high-risk patients with a history of malignant transformation in oral potentially malignant disorders. We will use a combination of Cardunil and all-trans retinoic acid for intervention. The effectiveness and safety of the combination therapy will be evaluated in the treatment of high-risk oral potentially malignant disorders, including the prevention of oral cancer recurrence and treatment of oral potentially malignant disorders. The findings of this study will provide evidence for tertiary prevention of oral cancer and the treatment of oral potentially malignant disorders.

Detection of Oral and Throat Cancers Using OralViome Cancer Testing System

To evaluate the design, safety and efficacy of OralViome Cancer Testing system in the early detection of Oral and Throat Cancers using saliva metatranscriptomic analysis. This study will recruit only at existing clinical sites and will NOT use any additional clinical sites.