Condition category
Cancer
Date applied
02/02/2012
Date assigned
29/02/2012
Last edited
01/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Gemma Jones

ORCID ID

Contact details

University Hospitals Coventry & Warwick
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 2476 964 000
Gemma.Jones@uhcw.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11317

Study information

Scientific title

Improving treatment selection using PREDICtive and prognostic classifiers of Treatment Response for Head and Neck Cancers and dysplasia

Acronym

PREDICTR-HNC

Study hypothesis

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

NRES Committee Covenry & Warwickshire, 14 November 2011 ref: 10/H1210/9

Study design

Observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Survival measured at the end of the study

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2012

Overall trial end date

21/04/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 1400

Participant exclusion criteria

1. No follow-up data
2. Not of stated primary site

Recruitment start date

01/05/2012

Recruitment end date

21/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry & Warwick (UK)

Sponsor details

University Suite
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhcw.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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