Clinical trial · Observational
Does Genetic Susceptibility for Bleeding Affect Quantitative Faecal Immunochemical Test (qFIT) Results?
Does Genetic Susceptibility for Bleeding Affect Quantitative Faecal Immunochemical Test (qFIT) Results? - a Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): never started due to funding/staffing issues
Summary
Brief summary (as posted)
Quantitative faecal immunochemical testing (qFIT) is used to test for blood within faeces that cannot always be visible. The presence of blood in the stool has been shown to be a finding where there may be a problem within the large bowel. The test is able to give a numeric value to the blood in the stool and based on this result, further investigations can be planned, or if normal reassurance given. The test is not perfect and minor bowel problems such as haemorrhoids (piles) can give a raised result. However, we have also seen raised results in people who when investigated have a completely normal large bowel. A small degree of 'physiological' non-visible bleeding is likely a normal part of life and for the majority this does not lead to a raised qFIT result. It may be the case in people who have a raised qFIT but then go on to have a completely normal colonoscopy (telescope investigation of the large bowel) that there is a genetic predisposition that increases the amount of normal 'physiological blood' that they produce. This leads to the test being falsely positive and the person undergoing an unnecessary investigation. This study aims to use saliva to test for known genetic markers that effect blood clotting and can increase how much someone bleeds. By comparing the occurrence of these genetic markers in people with a raised qFIT and normal colonoscopy to those with a normal qFIT and normal colonoscopy, we can test this theory. Should this be the case it will help explain why the test can be raised in normal large bowel and could lead to different levels of positivity being used for different people.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNP array | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Normal Colonoscopy and Normal qFIT
- description
- Normal colonoscopy and qFIT \<10 micrograms haemoglobin
- interventionNames
- Other: SNP array
- label
- Normal Colonoscopy and Raised qFIT
- description
- Normal colonoscopy and qFIT \>=10 micrograms haemoglobin
- interventionNames
- Other: SNP array
Primary outcomes (1)
- measure
- Accumulation of SNPs related to bleeding in patients with a normal colonoscopy and a raised qFIT compared to those with a qFIT less than 10 µg Hb/g.
- timeFrame
- Saliva sample will be collected within 1 month of recruitment. Assessment will require all results from the study participants before analysis can be performed. Aimed to be within 6 months of sample collection completion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who were symptomatic at the time of referral * Returned at least one qFIT sample * Underwent a complete colonoscopy, which did not identify any pathology * Willing to provide a saliva sample for genetic analysis * Are able to consent to the study Exclusion Criteria: * Age \< 18 * Previous colorectal cancer * Ongoing colonic polyp surveillance * Known inflammatory bowel disease * Taking anticoagulant medication (Aspirin, clopidogrel, warfarin or NOAC) * History of liver disease or known bleeding disorder * Incomplete colonoscopy * Unable to consent to the study
References
Publications (0)
Data not yet available