The National Institute for Health Research Diagnostic Evidence Co-operative Leeds (NIHR DEC Leeds) focuses on five main clinical areas - liver, urological, musculoskeletal, colorectal diseases and oncology.

Liver diseases
Theme leads: William RosenbergJulie Parkes, Rebecca Jones
Chronic liver disease (CLD) is the fifth commonest cause of death in the UK and is increasing mainly due to alcohol misuse, obesity and viral hepatitis. A minority of those at-risk develop liver injury and fibrosis that may progress to severe complications such as cirrhosis, liver cancer and/or liver failure. In the majority of those affected CLD remains asymptomatic until complications develop. Identification of at-risk individuals and an accurate assessment of the disease by in vitro diagnostic tests (IVDs) will permit better monitoring of CLD and allow for more effective interventions. IVD tests for liver fibrosis have been discovered and validated by us, opening the possibility of stratifying individuals and supporting behavioural modification. To date, IVDs have refined the management of Hepatitis B and Hepatitis C infection.

Urological diseases
Acute kidney injury (AKI) occurs in 5 to18 percent of hospital patients and 30 to 70 percent of patients in intensive care. Mortality has remained unchanged for the last 30 years (more than 50 percent). Chronic kidney disease (CKD) occurs in 40 percent of AKI survivors leading to 10 percent of patients requiring dialysis. CKD in the UK costs £1.45 billion per year. Biomarker-based IVDs are urgently needed for the early diagnosis and monitoring of kidney injury and disease to reduce morbidity, cost and allow early selection of patients for transplant.
Renal cancers are increasing with more than 10,000 new cases per year (UK). Locally advanced or metastatic disease affects over 50 percent. New drugs have improved response rates and survival but they are expensive. IVDs for diagnosis, prognosis and selection of therapy are urgently needed.
Prostate cancer accounts for nearly 11,000 deaths in the UK each year. Serum prostate-specific antigen (PSA) is a widely used biomarker but its value is limited by a lack of sensitivity and specificity. Improved IVDs are needed and would potentially impact all aspects of care, including diagnosis and monitoring treatment response.

Musculoskeletal diseases
Theme leads: Paul Emery, Ann Morgan
Musculoskeletal (MSK) disease, such as rheumatoid arthritis (RA) and scleroderma are devastating chronic diseases, causing severe joint damage, reduced life expectancy and poor general health if left untreated. Clinical decision making is confounded by variability between individuals in response to treatment and adverse reactions. No single agent achieves a successful outcome in more than 50 percent of patients. Newer drugs are more effective, but come at a high cost. There is a need to improve therapy using a targeted approach. IVDs to detect protein or genetic biomarkers may allow delivery of personalised medicine and improve monitoring for complications, such as lung fibrosis and cardiovascular disease. In Leeds, we have a large translational musculoskeletal research programme with extensive biobanks and intensely phenotyped RA cohorts, as well as drawing on our experience to support the DEC research programmes and evaluate candidate Musculoskeletal disease biomarkers.

Colorectal diseases
Theme lead: David Jayne
We are working in collaboration with the NIHR Colorectal Therapies Healthcare Technology Co-operative to identify and validate potential IVDs for colorectal diseases. Colorectal cancer (CRC) is the third most common cancer in the UK, affecting 37,000 people and resulting in 16,000 deaths per annum. The life time risk of being diagnosed with CRC is 1 in 16 for men and 1 in 18 for women. The NHS cost of treating bowel cancer was estimated to be over £1 billion in 2007. In addition to CRC, inflammatory bowel disease affects 1 in 250 of the UK population, equivalent to 13,300 new cases per annum. Many are diagnosed in their teens and early twenties, meaning a lifetime of potential morbidity. Diverticular disease affects 50 percent of those over 65 years. Complications arising from the disease account for eight percent of all non cancer-related gastro-intestinal mortalities in the UK. NHS data showed that in 2005 diverticular disease led to 217,000 bed days, and US audit data from 2004 estimated direct medical costs amounting to $2.6 billion.

Theme leads: Peter Selby, Naveen Vasudev, Gordon Cook
The NIHR DEC Leeds team also offer expertise in oncology. Our oncology areas include colorectal, liver and urological cancer, as described above, and breast cancer. The breast cancer portfolio has an applied methodological focus which has developed over a six year period. Its roots lie in the use of economic modelling to improve the design efficiency of industry and UK government funded randomised controlled trials of new pharmaceuticals. More recently these methods have been applied to NIHR HTA funded trials of diagnostic tests in early breast cancer, both during the diagnostic phase and the post-treatment monitoring phase. The methods under ongoing advancement within this theme will provide a foundation for design of the test development pipeline in the parallel themes.