Detection of bowel disease using cells from the colo

Not Applicable

Completed

• Conditions: Colorectal cancer; Cancer; Malignant neoplasm of other and ill-defined digestive organs

• Registration Number: ISRCTN77609648
• Lead Sponsor: Origin Sciences (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-16
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified