Head Neck CancerHPV & HNSCCNCT06642324
Human Papillomavirus Association and Genomic Exploration in Head-Neck Squamous Cell Carcinomas
An observational study of Head Neck Cancer and Oropharyngeal Neoplasms, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head Neck Cancer, Oropharyngeal Neoplasms
- What is being tested?
- Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing
- How many people
- 550 participants
- Where
- 1 siteBangladesh
- Study dates
- 30 Apr 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka, Dhaka Division, 1000
S M Rashed Ul Islam, M. Phil, MPH, +8801713236399, smrashed@bsmmu.edu.bd
Syed Farhan Ali Razib, FCPS, +8801714043556, razib10@bsmmu.edu.bd
About this study
Official title: Exploration of Human Papillomavirus Association and Genomic Characteristics in Head and Neck Squamous Cell Carcinomas in Bangladesh
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.
Read the 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.
- Conditions
- Head Neck Cancer, Oropharyngeal Neoplasms
- Being tested
- Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histopathology, Immunohistochemistry, Real-Time PCR, SequencingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| HPV Positive HNSCC Population | Tissues from Head Neck Squamous Cell Carcinoma and HPV DNA-positive Receives: Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing | |
| HPV Negative HNSCC Population | Tissues from Head Neck Squamous Cell Carcinoma and HPV DNA-negative Receives: 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. Receives: Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start30 Apr 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S M Rashed Ul Islam, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- S M Rashed Ul Islam, M. Phil, MPH, Principal investigator, Bangabandhu Sheikh Mujib Medical University (BSMMU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642324
- Sponsor's protocol ID
- BSMMU HNSCC Study-1
- Acronym
- HPV & HNSCC
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 23617206Gao 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.
PubMed 30975103Lechner 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.
PubMed 23718828Shaikh 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.
PubMed 29178862
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Human Papillomavirus Association and Genomic Characteristics in Head and Neck Squamous Cell Carcinomas in Bangladesh
- ClinicalTrials.gov ID
- NCT06642324
- Acronym / sponsor ID
- HPV & HNSCC / BSMMU HNSCC Study-1
- Conditions
- Head Neck Cancer, Oropharyngeal Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HPV Positive HNSCC Population | – | Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, SequencingTissues from Head Neck Squamous Cell Carcinoma and HPV DNA-positive |
| HPV Negative HNSCC Population | – | Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, SequencingTissues from Head Neck Squamous Cell Carcinoma and HPV DNA-negative |
| Healthy Population | – | Diagnostic Test: Histopathology, Immunohistochemistry, Real-Time PCR, SequencingHealthy Population who does not have any carcinoma, chronic diseases, Genetic diseases, acute/chronic infectious diseases, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Histopathology, Immunohistochemistry, Real-Time PCR, SequencingHistopathology 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. | Diagnostic test | HPV Negative HNSCC Population, HPV Positive HNSCC Population, Healthy Population |
Primary outcome
HPV positivity in histopathological positive HNSCC detected tissue samples
Time frame: 2 years
To detect and type the HPV DNA in HNSCC tissue samples utilizing Real-Time PCR and Histopathology.
1 secondary outcome
Genetic predisposition to HNSCC due to virus, Food habit or Tobacco
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 23617206Akhter 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.
- Background: PubMed 30975103Gao 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.
- Background: PubMed 23718828Lechner 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.
- Background: PubMed 29178862Shaikh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
S M Rashed Ul Islam, M. Phil, MPH principal investigator
Bangabandhu Sheikh Mujib Medical University (BSMMU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Neck Cancer and Oropharyngeal Neoplasms, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact S M Rashed Ul Islam, M. Phil, MPH (+8801713236399, smrashed@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV positivity in histopathological positive HNSCC detected tissue samples (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642324, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.