MedTrace Logo

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

NCT02037646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2017-10-27

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • April C Roslani, MBBCh · University of Malaya Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037646 on ClinicalTrials.gov