Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral

Study Overview
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Brief Summary
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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).

Detailed Description
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It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Qualitative fecal immunochemical test
* Other: Quantitative fecal immunochemical test
* Procedure: Colonoscopy
* Other: Cost analysis
* Other: Anxiety scores
* Other: Patient satisfaction scores


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Qualitative fecal immunochemical test<br>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. | Other: Qualitative fecal immunochemical test<br>* This test measures the amount of blood within the submitted stool specimen<br>Procedure: Colonoscopy<br>* Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.<br>Other: Cost analysis<br>* Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.<br>Other: Anxiety scores<br>* Hospital Anxiety and Depression Scale (HADS) questionnaire<br>Other: Patient satisfaction scores<br>* A 5-point patient satisfaction score will be documented at each patient visit related to screening.<br>|
| Other: Quantitative fecal immunochemical test<br>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. | Other: Quantitative fecal immunochemical test<br>* This test detects presence or absence of blood within a submitted stool specimen.<br>Procedure: Colonoscopy<br>* Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.<br>Other: Cost analysis<br>* Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.<br>Other: Anxiety scores<br>* Hospital Anxiety and Depression Scale (HADS) questionnaire<br>Other: Patient satisfaction scores<br>* A 5-point patient satisfaction score will be documented at each patient visit related to screening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to diagnosis of advanced colorectal neoplasms | Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm | 40-90 days from the time of enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of screening costs | Total costs incurred as a result of the screening process | Up to 90 days following enrolment | 
| Patient anxiety levels | As measured by the Hospital Anxiety and Depression Scale (HADS) | Up to 90 days after enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Screening, Fecal occult blood, Fecal immunochemical test, Qualitative, Quantitative