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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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. -

Trial population

A descriptive study will be conducted among head-neck squamous cell carcinoma people, who will be recruited after receiving informed written consent to participate. The study population will be recruited from the Department of Otolaryngology-Head \& Neck Surgery, histopathology of the BSMMU, and laboratory work will be done at the Department of Virology, BSMMU. During the specimen collection, brief demographic and clinical data will be collected through a pre-designed written questionnaire.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

550 Participants
are divided into 3 treatment groups
Group A: HPV Positive HNSCC Population1 intervention
Group B: HPV Negative HNSCC Population1 intervention
Group C: Healthy Population1 intervention

Trial outcomes

Primary outcomes

1

HPV positivity in histopathological positive HNSCC detected tissue samples

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

Time frame
2 years

Secondary outcomes

1

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

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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