Prevalence and clinical impact of Human Papilloma Virus in patients with Head and Neck Squamous Cell Cancer treated prospectively at Prince Aly Khan Hospital
- Conditions
- Health Condition 1: null- Squamous Cell Carcinoma of Head & Neck
- Registration Number
- CTRI/2011/04/001688
- Lead Sponsor
- Prince Aly Khan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 300
1.Pathologically (histologically or cytologically) proven AJCC/TNM staged diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses)
2.Zubrod Performance Status 0-1
3.Age 18years and above
4Patient must sign a study-specific informed consent prior to study entry, which includes mandatory submission of tissue for HPV analysis
1.Evidence of distant metastases or simultaneous primaries
2.Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin or untreated/treated low-risk prostate cancer(defined as clinical or pathologic T1c, N0 M0, PSA 10, Gleason 7, 50% of the total cores positive for cancer);
3.Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
4.Prior radiotherapy to the head and neck area that would result in overlap of radiation therapy fields.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The prevalence of HPV infection in oral, oropharyngeal, laryngeal and hypo pharyngeal cancersTimepoint: At diagnosis
- Secondary Outcome Measures
Name Time Method Correlation of HPV prevalence and Locoregional control and survival at 3 yearsTimepoint: Effect of Treatment in HPV positive cases with patient follow up till 3 years