PredicTR 2
Research type
Research Study
Full title
Validating the PredicTR treatment response classifier for oropharyngeal cancer (PredicTR 2)
IRAS ID
250130
Contact name
Hisham Mehanna
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Oropharyngeal cancer (OPC) - throat cancer - is one of the most rapidly rising cancers in the West, with ~115,000 new cases per year. This is due mainly to increased human papillomavirus (HPV)-related incidence. Standard treatment for OPC involves chemotherapy and radiotherapy. Adding surgery may improve outcomes for those patients most at risk of recurrence, but may also result in increased complications and poorer function as well as increased cost.
We have developed a 'biomarker-based test' to predict which OPC patients will receive most benefit from additional surgery, and so could guide treatment decision-making. We intend to complete clinical validation of our biomarker test and convert it into a standardised assay which may be adopted into clinical practice. We will do this by:
1 Replacing one of the antibodies used to detect the biomarker Survivin with a CE marked product. We will demonstrate equivalence with the research use only reagent used during development by staining samples from a previously tested cohort, in a bridging study.
2. Investigating the potential to replace manual scoring of the biomarker tumour infiltrating lymphocytes (TILs) by pathologists with a computer based automated algorithm. This has the potential to improve reproducibility and time taken to score. We have already developed an artificial intelligence-based algorithm for scoring TILs on digitised images in oral cancer. We will optimise then compare its ability to predict overall survival versus scoring by pathologists on OPC samples.
3. Testing the reproducibility of the biomarker-based test on whole tissue sections. If poorly reproducible, a qualitative study and further experiments will be done to address causes.
4. Validating the biomarker-based test in a prospective, independent external cohort under routine clinical conditions. OPC samples, already collected prospectively, will be stained and scored at 6 NHS laboratories. The performance and prediction accuracy of the test will then be evaluated.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0432
Date of REC Opinion
1 Nov 2018
REC opinion
Favourable Opinion