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

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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Qualitative fecal immunochemical test; Procedure: Colonoscopy; Other: Cost analysis; Other: Anxiety scores; Other: Patient satisfaction scores; Other: Quantitative fecal immunochemical test

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University of Malaya Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Qualitative fecal immunochemical test; 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; This test measures the amount of blood within the 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.
Other: Quantitative fecal immunochemical test; 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.	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.; Other: Quantitative fecal immunochemical test; This test detects presence or absence of blood within a submitted stool specimen.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: April C Roslani, MBBCh, University of Malaya Medical Centre

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Colorectal cancer; Qualitative; Screening; Fecal immunochemical test; Quantitative; Fecal occult blood
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 926.24