FOB testing for GI malignancy in IDA
Research type
Research Study
Full title
The role of faecal occult blood testing in risk stratification for GI malignancy in subjects with iron deficiency anaemia
IRAS ID
201759
Contact name
Jonathon Snook
Contact email
Sponsor organisation
Poole Hospital NHSFT
Duration of Study in the UK
2 years, 0 months, days
Research summary
Iron deficiency anaemia (IDA) is a common clinical problem. About 10% of males and post-menopausal females with IDA have underlying gastrointestinal (GI) malignancy, often in the absence of other clinical pointers to the diagnosis. Bidirectional endoscopy (BDE) is generally accepted as the most efficient method of investigating the GI tract in IDA. BDE is labour-intensive however, most examinations are negative for cancer, and the procedure carries a small but significant risk of complications - particularly high risk patients.
Previous studies have confirmed that three simple and objective clinical variables - age, sex and haemoglobin concentration – are independent predictors of GI malignancy in IDA. Utilising the combined variables, subjects with IDA can be allocated to subgroups with cancer risks ranging from less than 2% to more than 20%.
Faecal occult blood testing is a simple investigation for detecting small quantities of blood in stool, at levels far below that required for detection by the human eye. The development of faecal immunochemical testing (FIT) for haemoglobin has benefits include enhanced sensitivity for pathology, with figures of 61 – 91% for colorectal cancer.
The question addressed by the proposed study is whether FIT can provide an independent predictor of GI malignancy risk over and above the clinical predictors detailed above, so allowing further refinement of the risk stratification of patients with IDA prior to invasive investigation. The ultimate aim is to identify relatively large sub-groups of patients who are either at high risk, and so warrant fast-track BDE; or at such low risk that they can reasonably be managed without the need for invasive investigation.
The study plan involves determining the FIT status of about 360 subjects referred for the investigation of IDA, and comparing the subsequent cancer yield for those who are FIT-positive with those who are FIT-negative.REC name
London - South East Research Ethics Committee
REC reference
16/LO/1464
Date of REC Opinion
2 Aug 2016
REC opinion
Favourable Opinion