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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06642324
Acronym
HPV & HNSCC
Enrollment
550
Registered
2024-10-15
Start date
2024-04-30
Completion date
2025-09-30
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Neck Cancer, Oropharyngeal Neoplasms

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTHistopathology, Immunohistochemistry, Real-Time PCR, Sequencing

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.

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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. -

Design outcomes

Primary

MeasureTime frameDescription
HPV positivity in histopathological positive HNSCC detected tissue samples2 yearsTo detect and type the HPV DNA in HNSCC tissue samples utilizing Real-Time PCR and Histopathology.

Secondary

MeasureTime frameDescription
Genetic predisposition to HNSCC due to virus, Food habit or Tobacco2 yearsTo explore any influence of HPV positivity and food habits, like betel nut, betel leaf, tobacco, alcohol, etc, through genetic analysis.

Countries

Bangladesh

Contacts

Primary ContactS M Rashed Ul Islam, M. Phil, MPH
smrashed@bsmmu.edu.bd+8801713236399
Backup ContactSyed Farhan Ali Razib, FCPS
razib10@bsmmu.edu.bd+8801714043556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026