Colorectal cancer Cancer Malignant neoplasm of other and ill-defined digestive organs
Conditions
Interventions
Consecutive outpatient patients presenting with colorectal symptoms will be offered appropriate investigation of the bowel e.g. colonoscopy, barium enema, virtual colonoscopy. The precise investigatio
Sponsors
Origin Sciences (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 or over 2. Patients who have given written informed consent 3. If a woman of child-bearing potential, must have given a negative pregnancy test
Exclusion criteria
Exclusion criteria: 1. Patients less than 18 years old 2. Patients taking part in another clinical study 3. Patients unable to give clear written informed consent to the study 4. Patients with confirmed inflammatory bowel disease (IBD) 5. Patients with confirmed or suspected anal cancer 6. Patients with who have had any previous gastro-intestinal malignancy 7. Patients who have undergone previous colonic resection 8. Patients who have undergone chemotherapy or radiotherapy anytime within the last 6 months 9. Patients who have received any form of bowel preparation or contrast medium within the 14 days preceding the test 10. Patients who have received any form of anaesthesia in the 48 hours preceding the test 11. Patients with clear evidence of rectal cancer at proctoscope examination 12. Patients with an anal fissure, anal fistula, advanced haemorrhoids or any other condition that may make proctoscope introduction painful and/or dangerous in the eyes of the investigator 13. Patients with a faecally loaded rectum at proctoscope examination 14. Women who are pregnant or suspect that they may be pregnant 15. Patients with known Hepatitis B or HIV infection 16. Patients suffering from chronic alcohol abuse (over 30 units consumed per week on average) 17. Patients with a history of allergic reactions to compounds of similar chemical or biological composition to the device 18. Patients unable to comply with the protocol requirements (compliance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of correlations between DNA concentrations extracted from the rectal mucosa (DNA score) and final diagnosis in a cohort of consecutive symptomatic patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Information on DNA score ranges for individuals without colorectal conditions (no abnormality detected [NAD]) and on groups of patients with pathological conditions of different severity (IBD, polyps, diverticular disease, inflammation) 2. Determination of the optimal DNA score value as the cut-off point for selecting patients for further investigation | — |
Countries
United Kingdom
Outcome results
None listed