A study to investigate HPV-detect, a new way to measure the response to treatment in patients with Human Papilloma Virus (HPV) positive head and neck cancer
Not Applicable
- Conditions
- Head and neck cancerCancer
- Registration Number
- ISRCTN32335415
- Lead Sponsor
- The Institute of Cancer Research, London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 191
Inclusion Criteria
1. Aged 18 years or above.
2. Newly diagnosed patients with T1-T2/N1-3 or T3-T4/ N0-3 squamous cell carcinoma of the oropharynx
3. Availability of tissue from one archival diagnostic tumour tissue block
4. Confirmed HPV status (p16InK4A IHC/ISH)
5. Patients must be candidates for and willing to undergo curative RT/CRT
6. Written informed consent
Exclusion Criteria
1. Previous or concurrent illness or situation, which in the investigator’s opinion would interfere with collection of the complete sample collection
2. Any invasive malignancy within previous 5 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ
3. Clinical evidence of metastatic disease
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The specificity of HPV-detect (using plasma HPV DNA levels) in correctly identifying those with no residual disease, at 3 months following completion of primary RT/CRT; defined as the proportion of patients who are HPV-detect negative among those with no residual disease according to 18F-FDG PET at the same timepoint.
- Secondary Outcome Measures
Name Time Method