Using two FIT tests in symptomatic patients prior to colonoscopy can be a useful preselection tool to determine the need for colonoscopy in symptomatic patients.
ID
Bron
Verkorte titel
Aandoening
Colorectal cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The performance of 2-sample FIT to detect advanced neoplasia by defining its negative predictive value, positive predictive value, sensitivity and specificity.
Achtergrond van het onderzoek
Rationale: In patients with bowel symptoms a colonoscopy is performed to rule out or
diagnose a clinical relevant lesion. In most of these colonoscopies a significant abnormality is
not found. However, colonoscopy is not without risk, is time-consuming, may cause
discomfort and is costly. In order to decrease the number of unnecessary colonoscopies,
high risk symptom based referral criteria for colonoscopy have been developed (e.g. NICE
criteria). However, symptoms alone are poor predictors of the underlying pathology. Noninvasive
faecal immunochemical testing (FIT) could be a useful preselection tool to
determine the need for colonoscopy in symptomatic patients. Earlier studies have shown that
FIT has very high negative predictive values for colorectal cancer (CRC) ranging from 99-
100%, suggesting it could be used to rule out CRC and avoid colonoscopy. Up until now,
studies showing this considerable potential of FIT included small groups of patients. Larger
studies are needed to give a more reliable conclusion. Also, studies focus mainly on ruling
out CRC, while also high negative predictive values for advanced adenomas (AA) are
warranted to prevent patients to develop CRC in the (near) future. Studies have shown lower
negative predictive values of around 95% for advanced neoplasia (CRC and AA) then for
CRC alone. Some studies have hypothesized that doing two FIT’s might result in higher
negative predictive values, but research on this topic is scarce.
Objective: To evaluate the performance of two-sample FIT as a preselection tool for
colonoscopy in symptomatic patients.
Study design: Prospective observational cohort study.
Study population: 807 symptomatic patients referred for diagnostic colonoscopy.
Intervention: Subjects will be asked to complete two FIT’s prior to their colonoscopy.
Main study parameters/endpoints: Performance of two FIT’s in two executive bowel
movements to assess the yield of advanced neoplasia in symptomatic patients (negative
predictive value, positive predictive value, sensitivity and specificity).
Doel van het onderzoek
Using two FIT tests in symptomatic patients prior to colonoscopy can be a useful preselection tool to
determine the need for colonoscopy in symptomatic patients.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
None
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Referral for a diagnostic colonoscopy because of (new) bowel symptoms.
2. Able to undergo colonoscopy.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Subjects will be excluded if they are referred for colonoscopy surveillance for other
indications (including hereditary CRC syndrome, familial CRC syndrome, inflammatory
bowel disease, history of colorectal adenoma or CRC)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7966 |
| Ander register | METC Erasmus MC : MEC-2019-0381 |