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What is the role of Cohort Studies and Biobanking?

tgu-logo.jpgCohort studies are a method by which clinicians and scientists can observe and analyse a population of patients over time. Cohorts offer powerful methods to rapidly investigate the clinical relevance of emergent science. The resulting well characterised and annotated database of a large number of individual patients will allow us to recognise potential correlations between genetics, immunology and disease patterns. Furthermore it facilitates identification of specific populations suitable for other experimental medical studies, including the early stage study of novel therapeutic agents. Such experimental interventions are not confined to drugs but might include surgical procedures, devices or new paradigms of clinical management including increased patient participation.

The Oxford Gastrointestinal Illness Cohort and Biobank offers an important support to cohort studies focussing on particular diseases, such as Crohn’s disease or ulcerative colitis, for determining biomarkers of disease, distinguishing disease-specific pathological change from reactive change, and creating reference ranges for new and established bio-analytes.

Understanding the underlying processes that contribute to these diseases, and appropriately treating them requires a concerted effort of research and development, and central to such efforts is access to appropriately collected data and biological tissues and samples. In the TGU we aim to collect such data and tissues from patients attending the Oxford Radcliffe Hospitals, and to establish a Biobank of Gastrointestinal samples associated with high quality anonymised clinical data.

Why is our Biobank unique?

The cohort proposed here will be unique in that it will include specific subgroups of patients with a gastrointestinal complaint or some other reason, who are in contact with the Oxford University Hospitals. This includes those in whom no structural abnormalities are detected, such as patients with Irritable Bowel Syndrome (IBS). This is an important group to be studied in its own right, and also provides an excellent group for comparison with patients with conditions such as Inflammatory Bowel Disease (IBD).

The design will incorporate a biobank of DNA, serum, plasma or other body fluids, primary cells and cell lines, and tissue samples. Detailed characterisation of patients will facilitate stratification and allow relevant and precise surrogate markers, such as physiological function and changes in imaging, immunological markers and histopathology to be used to assess the impact of interventions in well-targeted proof-of-concept studies. The GI Biobank and IBD Cohort are part of the Oxford BioResource (OBr).

How can patients help?

When patients come to see their doctor within the Oxford University Hospitals NHS Trust they might be asked whether they would like to help by donating samples to the biobank. Their decision will not affect your treatment or care in any way. If a patient is asked whether he or she would like to donate samples to the biobank, they will be given a copy of the Patient Information Leaflet (PIL) to read which gives more information about the biobank.

Before taking part in the Oxford Gastrointestinal Illness Cohort and Biobank, a trained member of the biobanking team will talk to the patient through the informed consent process.

If, for any reason, however, the patient does not want to continue his or her participation, they can withdraw from the study at any time without disclosing a reason.