Human Papillomavirus Association and Genomic Exploration in Head-Neck Squamous Cell Carcinomas

Last updated: December 28, 2024
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Head And Neck Cancer

Lung Cancer

Carcinoma

Treatment

Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing

Clinical Study ID

NCT06642324
BSMMU HNSCC Study-1
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient Age: adult (> 18 years)

  2. Head and neck squamous cell carcinoma diagnosed by biopsy (Histopathology confirmedHNSCC).

  3. Diagnosed cases specific Head-Neck sub-sites: (oral cavity, oropharynx, hypopharynx,larynx, tongue)

  4. Patient's Consent

Exclusion

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. -

Study Design

Total Participants: 550
Treatment Group(s): 1
Primary Treatment: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing
Phase:
Study Start date:
April 30, 2024
Estimated Completion Date:
September 30, 2025

Study Description

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.

Connect with a study center

  • Bangabandhu Sheikh Mujib Medical University (BSMMU)

    Dhaka, 1000
    Bangladesh

    Active - Recruiting

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