Investigation of novel plasma Human Papilloma Virus DNA assay for treatment response estimation in head and neck cancer.
Disease site: Oropharyngeal cancer
Treatment modality: Chemo-radiotherapy or radiotherapy alone
Status: In Follow up
INOVATE is a multicentre prospective biological sample collection and analysis study, which aims to validate circulating Human Papilloma Virus (HPV) DNA as a marker of residual disease in patients with HPV positive oropharyngeal cancer (OPC).
The study recruited 191 patients with confirmed locally advanced oropharyngeal cancer (OPC), comprising 150 HPV+ OPC patients and 41HPV- OPC patients. Participants were candidates for standard of care, either radical radiotherapy alone or chemotherapy and radiotherapy.
Pre-treatment blood samples were collected for all patients and, from consenting HPV+ patients only, weekly during - and where possible weekly for 4 weeks after - radiotherapy or chemo-radiotherapy treatment.
Blood samples continue to be collected for all patients at 6 weeks and 3, 6, 9 and 12 months post treatment.
All patients donated archival formalin fixed paraffin embedded block from biopsies obtained for diagnosis. In HPV+ patients additional blood sample and tissue samples are being collected, when appropriate, at the time of any post radiotherapy surgical procedures and/or biopsies. Participants will be followed up for a total of 12 months following radiotherapy treatment.
Chief Investigator: Dr Shreerang Bhide, The Institute of Cancer Research/The Royal Marsden NHS Trust
ICR-CTSU Scientific Lead: Dr Maggie Cheang
Study Management Contact: [email protected]
Sponsor: The Institute of Cancer Research
Funding: Medical Research Council Developmental Pathway Funding Scheme
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