Rectal mucus sampling to assess for biomarkers of GI disease.
Research type
Research Study
Full title
Rectal mucus sampling to assess for biological markers of gastro-intestinal disease.
IRAS ID
157867
Contact name
Colin Ferrett
Contact email
Sponsor organisation
Oxford University Hospitals NHS Trust
Research summary
Participants will be identified following referral by their GP to specialist outpatient clinics (colorectal and gastroenterology) or the ward for investigation of bowel symptoms suspicious of colon or GI cancer. These patients will be sent details of the study (patient information sheet and invitation letter) with their next clinic appointment letter. During the clinic visit patients who are interested in taking part will be given an opportunity to further discuss the study with members of the research team and have questions answered before signing the consent form. Once the patient enters the study they will undergo a rectal examination (standard procedure when investigating bowel cancer). During the rectal examination the clinician will take a sample of rectal mucus using a rectal balloon. Participants will continue with standard appropriate clinical investigations as part of their normal care pathway. Participants who are diagnosed with cancer and a bowel resection is indicated as part of their cancer treatment will be asked to consent to the donation of surplus tissue which will be taken from the area removed during surgery.
Samples taken from rectal mucus (in the outpatient clinic) and tissue samples from the pathology departmental tissue bank, will be sent for analysis to a laboratory within the UK. The samples will be anonymised before they the hospital so that they will not be identifiable to researchers in the laboratory. The samples will be given a unique personal identifier which only the researcher in Oxford, will be able to use to identify the participant. Participants who require surgery will be asked to donate surplus tissue obtained during surgery and this will be matched with the mucus sample taken at the outpatient clinic visit (visit 1)
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1099
Date of REC Opinion
29 Jul 2014
REC opinion
Further Information Favourable Opinion