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

NCT06642324 | Recruiting FDA Device

• 1 other identifier: BSMMU HNSCC Study-1
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Neck Cancer; Oropharyngeal Neoplasms

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (3)

HPV Positive HNSCC Population

Tissues from Head Neck Squamous Cell Carcinoma and HPV DNA-positive

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

HPV Negative HNSCC Population

Tissues from Head Neck Squamous Cell Carcinoma and HPV DNA-negative

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

Healthy Population

Healthy Population who does not have any carcinoma, chronic diseases, Genetic diseases, acute/chronic infectious diseases, etc.

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

Interventions

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.

HPV Negative HNSCC Population; HPV Positive HNSCC Population; Healthy Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University (BSMMU)

Dhaka, Dhaka Division, 1000, Bangladesh

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy sample, Mouth wash, whole blood, serum, paraffin embedded tissue

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms

Interventions

Immunohistochemistry; Base Sequence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• S M Rashed Ul Islam, M. Phil, MPH

  Bangabandhu Sheikh Mujib Medical University (BSMMU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

S M Rashed Ul Islam, M. Phil, MPH

CONTACT

+8801713236399; smrashed@bsmmu.edu.bd

Syed Farhan Ali Razib, FCPS

CONTACT

+8801714043556; razib10@bsmmu.edu.bd

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: April 30, 2024
• Primary Completion: March 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)