Study Results
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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COMPLETED
58 participants
OBSERVATIONAL
2020-10-20
2023-02-07
Brief Summary
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Our study will analyse FIT results in recently diagnosed CRC patients to determine the risk of a false-negative FIT result and evaluate whether repeated analysis improves diagnostic accuracy. The study aims to advise on whether there is an optimal interval between sample collection to improve diagnostic accuracy and whether any patients are at risk of a false negative based on demographics, medications or other pathological factors.
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Detailed Description
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The Faecal Immunochemical Test (FIT) is replacing the less accurate Faecal Occult Blood Test (FOBT) in the UK and has the potential to help achieve earlier stage diagnosis of CRC. Whilst FIT has been validated as a screening test for the Bowel Cancer Screening Programme (BCSP), its role in diagnosing CRC in symptomatic populations is yet to be defined.
Nottingham is a pioneering centre using FIT to stratify risk and determine first-investigation in its two-week-wait (2WW) pathway. To optimise use of FIT and minimise the chance of missed cancers, this project aims to better understand variation of FIT results over time and how certain factors affect FIT result.
Much of the literature has focused on the evaluation of FIT in an asymptomatic population, which is inherently low risk (4,6,7). Expanding use of FIT to stratify risk and guide investigations for cancer in (higher risk) symptomatic populations necessitates a thoroughly evaluated testing strategy. At present there is insufficient information to advise on "negative" FIT results in symptomatic patients. This study will comprehensively measure FIT variation over time in patients with the target condition (CRC) and help answer whether additional samples are likely to improve accuracy of FIT.
Risk factors for false positives and false negatives have been previously identified but are not widely established (4). Our study will record the presence of these risk factors, and evaluate their effects on FIT-positivity with subsequent statistical analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Colorectal cancer
Patients recently diagnosed colorectal cancer
Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo
Quantitative Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo
Interventions
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Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo
Quantitative Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Not attending Nottingham University Hospitals for diagnosis/treatment (attending another trust)
* No histological diagnosis of colorectal cancer
* Unable to provide informed consent - for example due to language barriers or lacking capacity to join study
18 Years
ALL
No
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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David Humes, MBBS
Role: PRINCIPAL_INVESTIGATOR
Nottingham University Hospitals NHS Trust
Locations
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Queens Medical Centre
Nottingham, Nottinghamshire, United Kingdom
Countries
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Other Identifiers
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19ON031
Identifier Type: -
Identifier Source: org_study_id
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