- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04146662
Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection (FASt)
November 20, 2020 updated by: University Hospitals Coventry and Warwickshire NHS Trust
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
Intervention / Treatment
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
- Name: Subashini Chandrapalan, MD
- Phone Number: 02476 966907
- Email: subashini.chandrapalan@nhs.net
Study Contact Backup
- Name: Shivam Joshi, BSc
- Phone Number: 02476 966907
- Email: shivam.joshi@uhcw.nhs.uk
Study Locations
-
-
-
Coventry, United Kingdom, CV2 2DX
- Recruiting
- University Hospitals Coventry & Warwickshire NHS Trust
-
Contact:
- Subashini Chandrapalan, MD
- Phone Number: 02476 966907
- Email: subashini.chandrapalan@nhs.net
-
-
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
Additional Relevant MeSH Terms
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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