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NCT Number: NCT06642324

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bangabandhu Sheikh Mujib Medical University (BSMMU)

Dhaka, Dhaka Division, 1000, Bangladesh

Location status: Recruiting

Location contact

Afzalun Nessa, M. Phil

CONTACT

Bishnu Pada Dey, MD

CONTACT

S M Rashed Ul Islam, M. Phil, MPH

CONTACT

[email protected]

+8801713236399

Syed Farhan Ali Razib, FCPS

CONTACT

[email protected]

+8801714043556

Syed Farhan Ali Razib, FCPS

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient Age: adult (> 18 years)
  • Head and neck squamous cell carcinoma diagnosed by biopsy (Histopathology confirmed HNSCC).
  • Diagnosed cases specific Head-Neck sub-sites: (oral cavity, oropharynx, hypopharynx, larynx, tongue)
  • Patient's Consent

Exclusion criteria

  • Patient Age: children (< 18 years)
  • Cancers of any part of the body other than the head-neck region.
  • People without HNSCC
  • Any chronic diseases, genetic diseases, acute/chronic infectious diseases, etc. -

Treatment and study plan

Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing

Diagnostic Test

Histopathology for carcinoma detection, Immunohistochemistry for carcinoma-related protein expression, Real-Time PCR for HPV association and HPV typing, Sequencing for genetic study or mutation analysis.

Primary outcomes

  1. HPV positivity in histopathological positive HNSCC detected tissue samples

    Time frame: 2 years

    To detect and type the HPV DNA in HNSCC tissue samples utilizing Real-Time PCR and Histopathology.

Secondary outcomes

  1. Genetic predisposition to HNSCC due to virus, Food habit or Tobacco

    Time frame: 2 years

    To explore any influence of HPV positivity and food habits, like betel nut, betel leaf, tobacco, alcohol, etc, through genetic analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

S M Rashed Ul Islam, M. Phil, MPH

CONTACT

[email protected]

+8801713236399

Syed Farhan Ali Razib, FCPS

CONTACT

[email protected]

+8801714043556

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

Exploration of Human Papillomavirus Association and Genomic Characteristics in Head and Neck Squamous Cell Carcinomas in Bangladesh

Acronym: HPV & HNSCC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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