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

University of Malaya

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Patient satisfaction scores; Other: Cost analysis; Other: Qualitative fecal immunochemical test; Other: Anxiety scores; Other: Quantitative fecal immunochemical test; Procedure: Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02037646

926.24

Details and patient eligibility

About

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).

Full description

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

Enrollment: 700 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Qualitative fecal immunochemical test

Other group

Description:

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.

Treatment:

Other: Patient satisfaction scores

Procedure: Colonoscopy

Other: Qualitative fecal immunochemical test

Other: Anxiety scores

Other: Cost analysis

Quantitative fecal immunochemical test

Other group

Description:

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.

Treatment:

Other: Patient satisfaction scores

Other: Quantitative fecal immunochemical test

Procedure: Colonoscopy

Other: Anxiety scores

Other: Cost analysis