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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037646
• Other study ID #: 926.24
• Status: Completed
• Phase: N/A
• First received: January 14, 2014
• Last updated: October 25, 2017
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Qualitative fecal immunochemical test
This test measures the amount of blood within the submitted stool specimen
• 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.
• Anxiety scores
Hospital Anxiety and Depression Scale (HADS) questionnaire
• Patient satisfaction scores
A 5-point patient satisfaction score will be documented at each patient visit related to screening.

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analysis of screening costs	Total costs incurred as a result of the screening process	Up to 90 days following enrolment
Secondary	Patient anxiety levels	As measured by the Hospital Anxiety and Depression Scale (HADS)	Up to 90 days after enrolment