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Completed

NCT Number: NCT04146662

Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faecal Immunochemical Test

Diagnostic Test

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

Other names: Urine volatile organic compounds

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study title

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

Acronym: FASt

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 31, 2019
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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