NCT02037646

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Qualitative fecal immunochemical test	This test measures the amount of blood within the submitted stool specimen
OTHER	Quantitative fecal immunochemical test	This test detects presence or absence of blood within a submitted stool specimen.
PROCEDURE	Colonoscopy	Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
OTHER	Cost analysis	Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
OTHER	Anxiety scores	Hospital Anxiety and Depression Scale (HADS) questionnaire
OTHER	Patient satisfaction scores	A 5-point patient satisfaction score will be documented at each patient visit related to screening.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2014-01-16
• Last updated: 2017-10-27

Locations

1 site across 1 country: Malaysia