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

Study Details

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.

Further Information

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]

ISRCTN: 32335415

Sponsor: The Institute of Cancer Research

Funding: Medical Research Council Developmental Pathway Funding Scheme

Publications and Presentations

There have been no presentations or publications to date.