Improving treatment selection for head and neck cancers and dysplasia

ISRCTN	ISRCTN07132994
DOI	https://doi.org/10.1186/ISRCTN07132994
Secondary identifying numbers	11317

Submission date: 02/02/2012
Registration date: 29/02/2012
Last edited: 01/12/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Head and neck cancer (HNC) and its treatments have considerable quality of life effects and therapeutic, rehabilitative and social costs for patient and NHS. Survival is relatively poor and has not improved a lot despite a choice of new treatments. Therefore there is a need to improve health outcomes.One of the main reasons for the problems above is that tumours have different biological characteristics. There is a need for better methods of prognostication and treatment selection taking into account the biological characteristics of disease. Recently there have been several publications showing that certain immunohistological biomarkers strongly predict response to chemoradiotherapy and significantly enhanced survival in cohorts of patients that have been recruited during RCTs. These include HPV, p16, EGFR and Bcl-2, CA-9. These studies have involved single or at most two markers at a time, and have not incorporated other known established prognostic factors such as stage of disease or smoking status. Further more these findings have not been validated independently on other cohorts. The aim of the study is to identify markers that can be used to determine whether patients with oropharyngeal cancer will respond to certain treatments before they receive their treatments. This will mean that patients will receive the most appropriate treatment and this would likely result in the best outcome for them.

Who can participate?
Any patient who has had treatment for oropharyngeal cancer

What does the study involve?
The samples and information of the treatment for that patient will be obtained from their base hospital. The samples will then be tested for the biomarkers that are being studied. The results will then be analysed to see if the biomarkers can predict the response from the treatment that the patient had.

What are the possible benefits and risks of participating?
Since this is a retrospective study that looks at what treatments patients already have, then there is no risk to patients. The benefits are that the results may help future patients.

Where is the study run from?
The study is run from the Institute of Head and Neck Studies and Education at the University Hospitals Coventry.

When is study starting and how long is it expected to run for?
The study starts in May 2012 and is running for two years.

Who is funding the study?
Cancer Research UK

Who is the main contact?
Gemma Jones
Gemma.Jones@uhcw.nhs.uk

Contact information

Mrs Gemma Jones
Scientific

University Hospitals Coventry & Warwick
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Phone	+44 2476 964 000
Email	Gemma.Jones@uhcw.nhs.uk

Study information

Study design	Observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Improving treatment selection using PREDICtive and prognostic classifiers of Treatment Response for Head and Neck Cancers and dysplasia
Study acronym	PREDICTR-HNC
Study objectives	Aims: The project will validate the use of molecular biomarkers to better select the management of individual patients with oropharyngeal cancer. This should improve survival and quality of care because patients will receive the treatments most likely to help them and avoid the unnecessary toxicity, morbidity and cost of potentially ineffective treatment. Objectives: To develop and validate biomarker prognostic (PC) and treatment response classifiers (TRC) to select those patients with oropharyngeal cancers most likely to respond to chemoradiotherapy or surgery. A PC and TRC are mathematical functions that translates clinical factors and biomarker values into a set of prognostic and predictive outcomes, which select and stratify patients for treatment.
Ethics approval(s)	NRES Committee Covenry & Warwickshire, 14 November 2011 ref: 10/H1210/9
Health condition(s) or problem(s) studied	Head and neck cancer
Intervention	The outcome data and samples of patients with oropharyngeal cancer receiving either chemoradiotherapy or surgery plus or minus chemo-radiotherapy are collated from each centre. Samples are then analysed using the selected biomarkers. Complex bioinformatics analysis is then undertaken to look at the prognostic and predictive effects of selected biomarkers. Followed up for 36 months.
Intervention type	Other
Primary outcome measure	Survival measured at the end of the study
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/05/2012
Completion date	21/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	UK Sample Size: 1400
Key inclusion criteria	1. Oropharyngeal (tonsil or base of tongue) squamous carcinoma 2. Has a minimum 3 year follow up or to recurrence or death if occured before 3 years 3. Treatment by chemoradiotherapy or by surgery +/- post operative RT or chemoradiotherapy 4. Has clinical data including TNM staging available 5. Formalin fixed, paraffin embedded tissue block available 6. Male & female participants
Key exclusion criteria	1. No follow-up data 2. Not of stated primary site
Date of first enrolment	01/05/2012
Date of final enrolment	21/04/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clifford Bridge Road

Coventry
CV2 2DX
United Kingdom

Sponsor information

University Hospitals Coventry & Warwick (UK)
Hospital/treatment centre

University Suite
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom

Website	http://www.uhcw.nhs.uk/
"ROR"	https://ror.org/025n38288

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

01/12/2016: No publications found in PubMed, verifying study status with principal investigator.