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Human Papillomavirus Association and Genomic Exploration in Head-Neck Squamous Cell Carcinomas (HPV & HNSCC)

B

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status

Enrolling

Conditions

Head Neck Cancer
Oropharyngeal Neoplasms

Treatments

Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing

Study type

Observational

Funder types

Other

Identifiers

NCT06642324
BSMMU HNSCC Study-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

550 estimated patients

Sex

All

Ages

18+ years old

Volunteers

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. -

Trial design

550 participants in 3 patient groups

HPV Positive HNSCC Population
Description:
Tissues from Head Neck Squamous Cell Carcinoma and HPV DNA-positive
Treatment:
Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing
HPV Negative HNSCC Population
Description:
Tissues from Head Neck Squamous Cell Carcinoma and HPV DNA-negative
Treatment:
Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing
Healthy Population
Description:
Healthy Population who does not have any carcinoma, chronic diseases, Genetic diseases, acute/chronic infectious diseases, etc.
Treatment:
Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing

Trial contacts and locations

1

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Central trial contact

Syed Farhan Ali Razib, FCPS; S M Rashed Ul Islam, M. Phil, MPH

Data sourced from clinicaltrials.gov

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