Clinical trial · Observational
4-week Serial FIT Analysis in Patients With CRC
Serial Faecal Immunochemical Testing in Patients With Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Assimilation of FIT into primary and secondary care diagnostic pathways will lead to an increased prominence of the investigation in the diagnosis of colorectal cancer (CRC). Questions remain about whether serial FIT analysis improves accuracy, and what factors affect it. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Colorectal cancer
- description
- Patients recently diagnosed colorectal cancer
- interventionNames
- Diagnostic Test: Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo
Primary outcomes (2)
- measure
- False negative FIT results - Determine the occurrence of falsely negative FIT results in the presence of colorectal cancer
- timeFrame
- 2 years
- description
- Determine the occurrence of falsely negative FIT results in the presence of colorectal cancer
- measure
- Number of participants who yield sequential FIT results in divergent strata used for clinical decision making
- timeFrame
- 2 years
- description
- Number of participants who yield sequential FIT results in divergent strata used for clinical decision making (FIT \<4 μg Hb/g faeces, 4-9.9 μg Hb/g faeces, 10-99.9 μg Hb/g faeces, 100-150 μg Hb/g faeces, \>150 μg Hb/g faeces)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed colorectal cancer Exclusion Criteria: * Less than 18 years old * 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
References
Publications (0)
Data not yet available