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Point of Care Faecal Immunochemical Testing for Colorectal Cancer

NCT04402424 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 631

Last updated 2021-03-05

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Faecal Immunochemical Testing

Stool samples for both point of care and laboratory based faecal immunochemical testing via device specific sampling sticks

Sponsors & Collaborators

  • University of Surrey

    collaborator OTHER

  • Bowel Cancer Screening Hub

    collaborator UNKNOWN

  • GUTS Fighting Bowel Cancer Charity

    collaborator UNKNOWN

  • Royal Surrey County Hospital NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2020-08-16
Completion
2020-08-16

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04402424 on ClinicalTrials.gov