Direct link to this page: http://www.hta.ac.uk/1713

Details of HTA project in progress

Last updated: 1 July 2008 - Next update due: 8 July 2008


Research type:

HTA Technology Assessment Report  

Project title:

Systematic review of the clinical and cost-effectiveness, and economic evaluation, of photodynamic diagnosis and urine biomarker tests in the detection and follow-up of bladder cancer 

Project ref:

07/02/01 

Cost:

This project has been commissioned by the HTA programme on a call-off contract basis. 

Chief Investigator :

Aberdeen HTA Group, University of Aberdeen

Start Date:

October 2007.  

Publication date:

Late 2008. This date takes account of time for report preparation and printing based on current average times for these activities.  

Plain English Summary

Bladder cancer is a common cancer in the UK, affecting more than 10,000 people each year. It occurs most commonly in those between 50 and 70 years of age and is twice as common in men as in women. Around 70% of patients are diagnosed as having superficial (confined to the bladder lining) disease, which, despite treatment, has a high recurrence rate of 50% to 80%.

Patients with suspected bladder cancer initially undergo a voided urine cytology test (a test involving the examination of cells found in voided urine to detect the presence of cancerous cells), frequently along with the standard test for detecting bladder cancer, white light cystoscopy with examination of samples of abnormal tissue removed from the bladder wall. (Cystoscopy is a procedure in which a thin viewing tube (cystoscope) is passed through the urethra to examine the inside of the bladder.) However white light cystoscopy is an imperfect test and may fail to detect some tumours. Photodynamic diagnosis (PDD) is a test that can be used in addition to white light cystoscopy to improve tumour detection. The principle of PDD is based on the interaction between a photosensitising agent with a high selectivity for tumour cells and light with an appropriate wavelength (blue/violet light), which is absorbed by the agent and re-emitted with a different wavelength, causing tumours to fluoresce red. Also, a number of urine biomarker tests for detecting bladder cancer have been developed which, if they performed well enough, could potentially replace labour-intensive urine cytology and possibly some invasive cystoscopies.

This review will assess the clinical and cost-effectiveness of PDD and urine biomarker tests in patients (i) suspected of having bladder cancer and (ii) previously diagnosed with superficial bladder cancer and who are on follow-up cystoscopic examination.

The analysis will also focus on the impact that PDD and/or urine biomarkers for diagnosis have on treatment and tumour recurrence/disease progression at follow-up, and what the overall impact of introducing these techniques would be on NHS services and patient morbidity and mortality. Cost-effectiveness will be assessed from the perspective of the NHS and personal social services.

Information on the clinical effectiveness of the various interventions will be derived by systematically reviewing relevant studies. Information on cost-effectiveness will be derived from an economic model which will be developed and which will use the findings of the systematic review of clinical effectiveness to help provide estimates of the relative cost-effectiveness of diagnostic and follow-up strategies that involve PDD and/or urine biomarker tests against each other and against a strategy not involving these tests. 

Abstract:

Subsidiary questions to be addressed include:

To what extent would the use of PDD and/or urine biomarkers:
(i) reduce recurrence at follow-up as a consequence of altered treatment?
(ii) decrease progression at follow-up as a consequence of altered treatment?

What would be the overall impact:
(i) on NHS services?
(ii) on morbidity and mortality?

The study will involve four related steps:
(i) Development of care pathways describing plausible strategies for the diagnosis and follow-up of people with bladder cancer;
(ii) A systematic review of PDD and urine biomarker tests, alone or in combination, in the diagnosis and follow-up of bladder cancer;
(iii) A structured review of the management of people diagnosed with bladder cancer, with associated costs and outcomes;
(iv) Economic modelling of cost-effectiveness, and cost-utility if possible, of alternative approaches in the diagnosis and follow-up of people with bladder cancer.


The National Coordinating Centre for HTA Programme commissioned this technology assessment report on behalf of the HTA Programme Director (PSG).  

NRR* number, if applicable:

 (*National Research Register) 

Project Protocol:

Project protocol not available

URL of this page:

http://www.hta.ac.uk/1713
Tue, 1 Jul 2008 13:15:40 +0100

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