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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02037646

Enrollment

700

Registered

2014-01-16

Start date

2012-06-30

Completion date

2016-12-31

Last updated

2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, Screening, Fecal occult blood, Fecal immunochemical test, Qualitative, Quantitative

Brief 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.

Interventions

OTHERQualitative fecal immunochemical test

This test measures the amount of blood within the submitted stool specimen

OTHERQuantitative fecal immunochemical test

This test detects presence or absence of blood within a submitted stool specimen.

PROCEDUREColonoscopy

Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.

OTHERCost analysis

Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.

OTHERAnxiety scores

Hospital Anxiety and Depression Scale (HADS) questionnaire

OTHERPatient satisfaction scores

A 5-point patient satisfaction score will be documented at each patient visit related to screening.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026