Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection (FASt)

The Performance of Faecal Immunochemical Test and Urinary Volatile Compounds in the Detection of Colorectal Adenomas and Their Role in Polyp Surveillance

Bowel cancer can arise from polyps, which can become cancerous. Polyps are little outgrowths within the lining of the bowel (similar to skin warts). Depending on their size and their potential to become cancerous, they can cause bleeding. However, it is not known which polyps harbour cancerous potential. Therefore, at present all patients undergo a colonoscopy (camera examination of the large bowel) in order to identify and remove any polyps. However, not all patients who undergo a colonoscopy will have polyps. Moreover, colonoscopies are invasive and disruptive to patients, as they require bowel preparation. The aim of this study is to evaluate non-invasive stool and urine tests to identify patients who are at risk of polyps and if the polyps have the potential to become cancerous. This in turn, will significantly reduce the number of 'unnecessary' polyp surveillance colonoscopies with resultant benefits to both patients and the National Health Service (NHS).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

354

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults over 18 years who are known to have colorectal polyps and on polyp surveillance programme

Description

Inclusion Criteria:

  • Patients who are on a polyp surveillance programme and will be undergoing colonoscopy examination for polyp surveillance OR Patients who will be undergoing elective polypectomy through specialised polyp multi-disciplinary meetings.

Exclusion Criteria:

  • Participants who are unable to attend colonoscopy
  • Under 18 years old
  • Unable to provide informed consent for themselves to take part in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas
Time Frame: Through study completion, an average of 2 years
To determine the sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas - individually and in combination, in comparison to colonoscopy results (histology findings).
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas
Time Frame: Through study completion, an average of 2 years
To determine the specificity and receiver operator curve for Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas.
Through study completion, an average of 2 years
Positivity threshold for Faecal immunochemical test and urine volatile markers
Time Frame: Through study completion, an average of 2 years
To determine the positivity threshold for FIT and urine VOC for detection of adenomas, comparing all adenomas vs high grade adenomas.
Through study completion, an average of 2 years
Volatile chemicals in urine in those with adenomas
Time Frame: Through study completion, an average of 2 years
To identify the specific volatile chemicals that are consistently present in those with adenomas.
Through study completion, an average of 2 years
To determine the sensitivity of blood markers for the detection of colorectal adenomas
Time Frame: Through study completion, an average of 2 years
To determine the sensitivity of blood markers e.g. Septin 9 for the detection of colorectal adenomas
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 16, 2019

Primary Completion (ANTICIPATED)

March 31, 2021

Study Completion (ANTICIPATED)

March 31, 2022

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (ACTUAL)

October 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RA433019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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