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

NCT02037646 | Completed DMC

• 1 other identifier: 926.24
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Analysis of screening costs

  Up to 90 days following enrolment

• Patient anxiety levels

  Up to 90 days after enrolment

Study Arms (2)

Qualitative fecal immunochemical test

OTHER

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; Procedure: Colonoscopy; Other: Cost analysis; Other: Anxiety scores; Other: Patient satisfaction scores

Quantitative fecal immunochemical test

OTHER

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.

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

Interventions

Qualitative fecal immunochemical test OTHER

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

Qualitative fecal immunochemical test

Quantitative fecal immunochemical test OTHER

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

Quantitative fecal immunochemical test

Colonoscopy PROCEDURE

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

Qualitative fecal immunochemical test; Quantitative fecal immunochemical test

Cost analysis OTHER

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

Qualitative fecal immunochemical test; Quantitative fecal immunochemical test

Anxiety scores OTHER

Hospital Anxiety and Depression Scale (HADS) questionnaire

Qualitative fecal immunochemical test; Quantitative fecal immunochemical test

Patient satisfaction scores OTHER

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

Qualitative fecal immunochemical test; Quantitative fecal immunochemical test

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 50 years and above

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy; Costs and Cost Analysis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Economics; Health Care Economics and Organizations

Study Officials

• April C Roslani, MBBCh

  University of Malaya Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

MY (1)