Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection

NCT ID: NCT04146662

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-16

Study Completion Date

2022-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Faecal immunochemical test

Faecal immunochemical test (FIT) and urine volatile organic compounds (VOC) analysis.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Urine volatile organic compounds

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospitals Coventry & Warwickshire NHS Trust

Coventry, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RA433019

Identifier Type: -

Identifier Source: org_study_id

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