Clinical trial · Interventional
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
Evaluating the Effectiveness of Screening Strategies Using Quantitative Versus Qualitative Fecal Immunochemical Test (FIT) to Prioritize Urgency of Colonoscopy Referral - a Randomized Controlled Trial Protocol
NCT02037646CI-TRIAL-00030095completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anxiety scores | Other | — | UNRESOLVED |
| Colonoscopy | Procedure | — | UNRESOLVED |
| Cost analysis | Other | — | UNRESOLVED |
| Patient satisfaction scores | Other | — | UNRESOLVED |
| Qualitative fecal immunochemical test | Other | — | UNRESOLVED |
| Quantitative fecal immunochemical test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Qualitative fecal immunochemical test
- description
- Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows: \>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list \<100 ng/dL - no colonoscopy Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
- interventionNames
- Other: Qualitative fecal immunochemical test
- Procedure: Colonoscopy
- Other: Cost analysis
- Other: Anxiety scores
- Other: Patient satisfaction scores
- type
- OTHER
- label
- Quantitative fecal immunochemical test
- description
- Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows: Positive - colonoscopy as per waiting list Negative - no colonoscopy Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 50 years and above Exclusion Criteria: * Lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding * Personal history of colorectal tumour or cancer * Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
References
Publications (0)
Data not yet available
No reference posted for this study.