INOVATE

• Research type

  Research Study

• Full title

  Investigation of novel plasma Human Papilloma Virus DNA assay for treatment response estimation in head and neck cancer.

• IRAS ID

  237168

• Contact name

  Shreerang Bhide

• Contact email

  Shree.Bhide@icr.ac.uk

• Sponsor organisation

  The Institute of Cancer Research

• Duration of Study in the UK

  4 years, 2 months, 31 days

• Research summary

  Approximately 2000 patients are diagnosed annually in the UK with oropharyngeal (throat) cancer caused by human papillomavirus (HPV) infection. The standard treatment is chemotherapy and radiotherapy followed by surgical removal of any cancer left behind. The surgery is undertaken based on results of a scan (18F-FDG PET-CT). However, approximately 20-30% of patients will receive unnecessary surgical intervention, as residual cancer is not confirmed on pathological examination post-surgery. Following surgery approximately 25% of patients will have immediate complications and all will suffer significant permanent side effects (pain, shoulder dysfunction, altered quality of life). Therefore a more reliable marker of true residual disease is required as a means of guiding management decisions.
  As HPV positive(+) oropharyngeal cancers release HPV-DNA into the blood stream its presence can serve as a detection marker of residual cancer after treatment. HPV-detect, an assay developed and tested in a single-centre, prospective pilot study at the Royal Marsden Hospital/Institute of Cancer Research, is a way to measure HPV-DNA levels using a blood test. Further validation of HPV-detect is now required in a prospective multi-centre study. The study is needed to establish its usefulness in patient care and evaluate its potential to predict the absence of residual disease and avoid unnecessary surgery. INOVATE is a multicentre study which aims to collect biological samples from 143 HPV+ and 48 HPV negative patients with oropharyngeal cancer. Patients will be asked to donate archival diagnostic tumour tissue samples and blood samples taken at specified time points up to 1 year following treatment. HPV-DNA levels will be measured using HPV-detect and the results correlated with the 18F-FDG PET-CT results at 12 weeks. In addition, barriers to adoption of the test and how to address these will be studied. A health economic analysis will study the cost benefits of implementing the test in the UK.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  19/LO/1558

• Date of REC Opinion

  14 Oct 2019

• REC opinion

  Favourable Opinion