Clinical trial · Interventional
A Trial of the Implementation of iFOBT in General Practice
The Use of Immunochemical Faecal Occult Blood Test (iFOBT) in General Practice. A Randomised Trial of the Implementation of iFOBT.
- 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)
Background Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many patients present with uncharacteristic or vague symptoms. The faecal marker of human globin, iFOBT, could play an important role in aiding the general practitioner in detecting CRC. Hypothesis It will be possible to implement iFOBT in general practice as a test performed on patients who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose symptoms could indicate an undiagnosed colorectal cancer. Aim To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications. Materials and methods The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18 municipalities in the central Denmark Region, and these are randomised when to receive a continuous medical education (CME). The date of inclusion is defined as the first working day in the month the CME is planned to be conducted. The CME is part of an intervention aimed to facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention consist of a start package (iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The inclusion period is during the first 7 month of the study period, the study lasts for one year. Perspectives This study will provide important knowledge on how to improve CRC diagnostics in general practice.
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 |
|---|---|---|---|
| Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Before intervention
- description
- GPs in this group have not yet received intervention.
- type
- EXPERIMENTAL
- label
- After intervention
- description
- GPs in this group have received the intervention.
- interventionNames
- Behavioral: Intervention
Primary outcomes (6)
- measure
- The rate of positive iFOBTs
- timeFrame
- 1 year
- measure
- The number of CRCs diagnosed after a positive iFOBT
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * GPs in the Central Denmark Region * Patients \>30 years eligible for iFOBT according to guideline Exclusion Criteria:
References
Publications (1)
- DERIVEDJuul JS, Bro F, Hornung N, Andersen BS, Laurberg S, Olesen F, Vedsted P. Implementation of immunochemical faecal occult blood test in general practice: a study protocol using a cluster-randomised stepped-wedge design. BMC Cancer. 2016 Jul 11;16:445. doi: 10.1186/s12885-016-2477-9. PMID 27400657