Point of Care Faecal Immunochemical Testing for Colorectal Cancer
POCFIT
Can Point of Care Faecal Immunochemical Testing (FIT) be Used in a Clinical Setting for Triage to Endoscopy in the Management of Symptomatic Patients? Prospective Cohort Study to Compare the Results of Point of Care FIT With Endoscopy Findings for Symptomatic Patients Referred to Colorectal Clinic Under the Two-week Rule.
1 other identifier
observational
631
1 country
1
Brief Summary
Blood that can be detected in stool via faecal immunochemical testing is a recognised risk factor for the presence of colorectal cancer. There are a number of point of care faecal immunochemical testing devices available. This study is to trial one of these machines into the clinical setting to see if the results are safe and accurate as a 'rule out' test for colorectal cancer. We will be investigating patients that present with symptoms or anaemia to their GP and are referred on the two-week rule pathway to our hospital. It has also been advocated that digital rectal examination (which is part of the routine assessment for a patient presenting to colorectal clinic) provides an opportunity to use a small sample of stool from a gloved finger to perform faecal immunochemical testing. We will be comparing a patient provided sample with a DRE sample on a standard laboratory-based machine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2019
CompletedFirst Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2020
CompletedMarch 5, 2021
March 1, 2021
1.1 years
May 22, 2020
March 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colorectal Cancer
Detection of colorectal cancer via colonoscopy or CT colonography
28 days
Secondary Outcomes (1)
Other Significant Colorectal Disease
28 days
Study Arms (1)
Two-Week Rule Colorectal Patients
Patients that the GP has referred to two-week rule colorectal clinics at Royal Surrey County Hospital with bowel symptoms or found to be anaemic
Interventions
Stool samples for both point of care and laboratory based faecal immunochemical testing via device specific sampling sticks
Eligibility Criteria
Patients referred to two-week rule colorectal clinics
You may qualify if:
- Patients referred on TWR colorectal cancer pathway to clinic at the Royal Surrey County Hospital
- Age 18+
- Capacity to consent
You may not qualify if:
- Has a stoma
- Previous colorectal cancer
- Patients lacking capacity to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Surrey County Hospital NHS Foundation Trustlead
- University of Surreycollaborator
- Bowel Cancer Screening Hubcollaborator
- GUTS Fighting Bowel Cancer Charitycollaborator
Study Sites (1)
Royal Surrey County Hospital
Guildford, Surrey, GU2 7WG, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 26, 2020
Study Start
July 16, 2019
Primary Completion
August 16, 2020
Study Completion
August 16, 2020
Last Updated
March 5, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share
no patient information is to be shared