A case-control evaluation of the NHS Bowel Cancer Screening Programme
Research type
Research Study
Full title
An ongoing case-control study to evaluate the NHS Bowel Cancer Screening Programme (NHSBCSP)
IRAS ID
136325
Contact name
Stephen W. Duffy
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
106/0001,
Research summary
Background. Colorectal cancer is the second most common cancer in England: in men, it is the third most common cause of cancer death after prostate and lung cancer, and in women, the third after breast and lung cancer. A national bowel cancer screening programme began in July 2006 and rolled out incrementally across the country, achieving national coverage in 2010. In the post-randomised controlled trials epoch, assessment of the impact of the programme using observational studies is needed.
Objective. This study protocol addresses one of the central UK Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis questions: the effect of the current bowel screening programme on incidence of advanced primary colorectal cancer.
Methods. All incident cases of primary colorectal cancer in England within each study period will be included in this evaluation. Cases will be matched to controls with respect to sex, age, area of NHS registration and year of first invitation to screening. Each evaluation will cover a 2-year period, starting from January 2012, and ongoing thereafter. Variables related to colorectal tumour pathology will be obtained to enable selection and matching of cases and controls, and to allow analyses stratified by anatomical subsite within the bowel.
Published data on mortality ratio between controls (not invited) and invited but non-attendees observed in randomised controlled trials will be used to correct for self-selection bias in all individuals. Screening participation at other national screening programmes (breast, cervix) will also be collected to derive a more contemporaneous adjustment factor for self-selection bias and assess consistency in self-selection correction in female patients. The primary analysis will be of the subgroup of cases at Duke’s stage B or worse ("advanced stage"). In later study periods, when the prevalence screen is less dominant, further analyses will be undertaken to ascertain the effect of screening on incidence of colorectal cancer in general, regardless of stage. When the programme is mature, new studies will be designed based on mortality from colorectal cancer. In additional to the main analysis, subgroup analyses will be conducted by sex and anatomical subsite.In the first instance, a pilot will be carried out in a single region.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/0826
Date of REC Opinion
1 Aug 2014
REC opinion
Further Information Favourable Opinion