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

NCT ID: NCT06642324

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Head Neck Cancer Oropharyngeal Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HPV Positive HNSCC Population

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

Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing

Intervention Type 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

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

Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing

Intervention Type 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.

Healthy Population

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

Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing

Intervention Type 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.

Interventions

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Histopathology, 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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S M Rashed Ul Islam

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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S M Rashed Ul Islam, M. Phil, MPH

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University (BSMMU)

Locations

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Bangabandhu Sheikh Mujib Medical University (BSMMU)

Dhaka, Dhaka Division, Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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S M Rashed Ul Islam, M. Phil, MPH

Role: CONTACT

Phone: +8801713236399

Email: [email protected]

Syed Farhan Ali Razib, FCPS

Role: CONTACT

Phone: +8801714043556

Email: [email protected]

Facility Contacts

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S M Rashed Ul Islam, M. Phil, MPH

Role: primary

Syed Farhan Ali Razib, FCPS

Role: backup

Syed Farhan Ali Razib, FCPS

Role: backup

Bishnu Pada Dey, MD

Role: backup

Afzalun Nessa, M. Phil

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 23617206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30975103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23718828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29178862 (View on PubMed)

Other Identifiers

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BSMMU HNSCC Study-1

Identifier Type: -

Identifier Source: org_study_id