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

NCT06642324 — Recruiting, 550 participants, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06642324, acronym HPV & HNSCC
StatusRecruiting
Study typeObservational
Enrollment550 (Estimated)
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
ConditionsHead Neck Cancer, Oropharyngeal Neoplasms
InterventionsHistopathology, Immunohistochemistry, Real-Time PCR, Sequencing (Diagnostic test)
Datesstart 2024-04-30, primary completion 2025-03-30 (estimated), completion 2025-09-30 (estimated), first posted 2024-10-15, last updated 2024-12-31
Locations1 site in Bangladesh

Related Papers Related Patents Related Grants Related Experts
All trials for Head Neck Cancer All trials for Oropharyngeal Neoplasms All trials of Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
HPV Positive HNSCC PopulationDiagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, SequencingTissues from Head Neck Squamous Cell Carcinoma and HPV DNA-positive
HPV Negative HNSCC PopulationDiagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, SequencingTissues from Head Neck Squamous Cell Carcinoma and HPV DNA-negative
Healthy PopulationDiagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, SequencingHealthy Population who does not have any carcinoma, chronic diseases, Genetic diseases, acute/chronic infectious diseases, etc.
  • 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.

+Outcome measures

Primary outcomes

  • HPV positivity in histopathological positive HNSCC detected tissue samples [2 years]: To detect and type the HPV DNA in HNSCC tissue samples utilizing Real-Time PCR and Histopathology.

Secondary outcomes

  • Genetic predisposition to HNSCC due to virus, Food habit or Tobacco [2 years]: To explore any influence of HPV positivity and food habits, like betel nut, betel leaf, tobacco, alcohol, etc, through genetic analysis.

+Eligibility

Sex: All, ages: 18 Years to any, 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. -

+Locations (1)

FacilityCityCountryStatus
Bangabandhu Sheikh Mujib Medical University (BSMMU)Dhaka, Dhaka DivisionBangladeshRecruiting

+Publications

  • Akhter M, Ali L, Hassan Z, Khan I. Association of human papilloma virus infection and oral squamous cell carcinoma in Bangladesh. J Health Popul Nutr. 2013 Mar;31(1):65-9. doi: 10.3329/jhpn.v31i1.14750. PMID 23617206
  • Gao G, Wang J, Kasperbauer JL, Tombers NM, Teng F, Gou H, Zhao Y, Bao Z, Smith DI. Whole genome sequencing reveals complexity in both HPV sequences present and HPV integrations in HPV-positive oropharyngeal squamous cell carcinomas. BMC Cancer. 2019 Apr 11;19(1):352. doi: 10.1186/s12885-019-5536-1. PMID 30975103
  • Lechner M, Frampton GM, Fenton T, Feber A, Palmer G, Jay A, Pillay N, Forster M, Cronin MT, Lipson D, Miller VA, Brennan TA, Henderson S, Vaz F, O'Flynn P, Kalavrezos N, Yelensky R, Beck S, Stephens PJ, Boshoff C. Targeted next-generation sequencing of head and neck squamous cell carcinoma identifies novel genetic alterations in HPV+ and HPV- tumors. Genome Med. 2013 May 29;5(5):49. doi: 10.1186/gm453. eCollection 2013. PMID 23718828
  • Shaikh MH, Khan AI, Sadat A, Chowdhury AH, Jinnah SA, Gopalan V, Lam AK, Clarke DTW, McMillan NAJ, Johnson NW. Prevalence and types of high-risk human papillomaviruses in head and neck cancers from Bangladesh. BMC Cancer. 2017 Nov 25;17(1):792. doi: 10.1186/s12885-017-3789-0. PMID 29178862

+Investigators

  • S M Rashed Ul Islam, M. Phil, MPH, Principal investigator, Bangabandhu Sheikh Mujib Medical University (BSMMU)