Exploration of Human Papillomavirus Association and Genomic Characteristics in Head and Neck Squamous Cell Carcinomas in Bangladesh
| Registry | NCT06642324, acronym HPV & HNSCC |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 550 (Estimated) |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other) |
| Conditions | Head Neck Cancer, Oropharyngeal Neoplasms |
| Interventions | Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing (Diagnostic test) |
| Dates | start 2024-04-30, primary completion 2025-03-30 (estimated), completion 2025-09-30 (estimated), first posted 2024-10-15, last updated 2024-12-31 |
| Locations | 1 site in Bangladesh |
Related Papers Related Patents Related Grants Related Experts
All trials for Head Neck Cancer All trials for Oropharyngeal Neoplasms All trials of Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing
Head and neck squamous cell carcinoma (HNSCC) represents a significant public health burden in Bangladesh with a high incidence and mortality rate. While traditional risk factors like tobacco and betel nut chewing contribute to HNSCC incidence, the emergence of HPV-associated HNSCC presents a unique challenge. The main goal of this observational study is to explore the prevalence, risk factors, and biological mechanisms underlying food habits and HPV-driven HNSCC in the population and identify the genomic changes and characteristics related to this malignancy. This study will provide the prevalence of HPV-associated HNSCC and screening the HPV typing in the Bangladeshi population, identify risk factors, and any biologically driven mechanisms causing HNSCC.
Head and neck squamous cell carcinoma (HNSCC) represents Bangladesh's significant public health challenge. According to GLOBACAN data, these cancers are among the most prevalent malignancies in the country, with a considerable impact on morbidity and mortality rates. Several factors contribute to the high incidence of HNSCC in Bangladesh, including prevalent tobacco and betel nut chewing habits, poor oral hygiene practices, oncogenic viruses such as human papillomavirus (HPV), and limited access to healthcare facilities for early detection and treatment. In recent years, the incidence of HPV-associated HNSCC has been on the rise, posing a significant health concern globally. HPV16 and HPV18 have been strongly linked to the development of HNSCC. The global surge of HPV-associated HNSCC necessitates further investigation, particularly in regions like Bangladesh. By addressing these critical areas, this research has the potential to improve public health outcomes in Bangladesh significantly.
The main goal of this observational study is to explore the prevalence, risk factors, and biological mechanisms underlying food habits and HPV-driven HNSCC in the Bangladeshi population. Additionally, the study aims to identify the gene expression changes related to these factors.
At first, the HNSCC samples will be detected through histopathology analysis, followed by nucleic acid extraction from the carcinoma-positive samples. Subsequently, molecular screening will be conducted alongside an assessment of patient histories. Based on the results from the molecular screening, immunohistochemistry will be performed on both HPV-positive and HPV-negative HNSCC samples to assess carcinoma-related protein expression. Finally, a comprehensive cancer omics analysis will be conducted after obtaining the sequencing data. Understanding these aspects is crucial for developing targeted prevention strategies, including HPV vaccination campaigns and public health education initiatives on high-risk sexual behavior.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| HPV Positive HNSCC Population | Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing | Tissues from Head Neck Squamous Cell Carcinoma and HPV DNA-positive | |
| HPV Negative HNSCC Population | Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing | Tissues from Head Neck Squamous Cell Carcinoma and HPV DNA-negative | |
| Healthy Population | Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing | Healthy Population who does not have any carcinoma, chronic diseases, Genetic diseases, acute/chronic infectious diseases, etc. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: 1. Patient Age: adult (> 18 years) 2. Head and neck squamous cell carcinoma diagnosed by biopsy (Histopathology confirmed HNSCC). 3. Diagnosed cases specific Head-Neck sub-sites: (oral cavity, oropharynx, hypopharynx, larynx, tongue) 4. Patient's Consent Exclusion Criteria: 1. Patient Age: children (< 18 years) 2. Cancers of any part of the body other than the head-neck region. 3. People without HNSCC 4. Any chronic diseases, genetic diseases, acute/chronic infectious diseases, etc. -
| Facility | City | Country | Status |
|---|---|---|---|
| Bangabandhu Sheikh Mujib Medical University (BSMMU) | Dhaka, Dhaka Division | Bangladesh | Recruiting |