HPV in Head Neck Squamous Cell Carcinoma (HN-SCC) - Clinico- Pathologic management correlation : An Observational Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- HPV type and load related differences in disease progression and treatment response in HNSCC
Study Overview
Brief Summary
Cancer of the head and neck region is the commonest cancer in India and is the Commonest cause of cancer related death in India. Nearly 90% of cancers in the head and neck region is known as head and neck squamous cell Carcinoma- HNCC. A particular type of viral infection caused by Human Papilloma Virus is a common cause of HNSCC. The study aims to find out the following-To determine the overall incidence of various subtypes & viral load of HPV among HNSCC patients presenting in SGCCRI, Thakurpukur; To find out the relative incidences and viral load of virulent sub types of HPV in different sub-sites of HNSCC; Demographic and sub site analysis of the HPV- positive and HPV- negative HNSCC patients; Correlation between duration of symptoms and stage at presentation, between HPV (virulent sub types) positive & negative HNSCC patients. Secondarily it aims to find the : Treatment response, Time of recurrence, Nature of recurrence etc Meterials and Methods: Patients who are selected to be enrolled in the study are questioned and their clinical and Demographic data are recorded as per proforma; 5mm of fresh HNSCC tissue will be collected in proper collection medium and stored in -80 degree centigrade. DNA isolation will be done using standard kits. PCR based HPV detection and typing will be done. Quantitative viral load will be done by RT-PCT
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All patients diagnosed as suffering from HNSCC presenting in the Institute.
Exclusion Criteria
- •Immunocompromised patients: a) Previous chemotherapy due to any cancer b) Immunodeficiency status-latrogenic or disease indused 2) Previous Radiotherapy due to any cause 3) Where adequate biopsy sample cannot be obtained due to technical reasons.
Outcomes
Primary Outcomes
HPV type and load related differences in disease progression and treatment response in HNSCC
Time Frame: 3 years of recruitment followed by further 2 yrs of of follow up after the last recruitment.
Secondary Outcomes
- Site of Recurrence and time interval of recurrence following treatment of HNSCC dependant on HPV Subtype and viral load.(3 years of recruitment followed by further 2-5 yrs of of follow up after the last recruitment.)