NCT03367611

Use of iFOBT in Patients Presenting With Alarm Symptoms of Colorectal Cancer

Completed NA Last updated 2 March 2020

What this trial tests

NA trial testing Immunochemical faecal occult blood test (iFOBT) in Colorectal Neoplasms in 1,258 participants. Completed in 31 December 2019.

Timeline

15 March 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	1,258
Start date	15 March 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across Denmark

Drugs / interventions tested

• Immunochemical faecal occult blood test (iFOBT)

Conditions studied

• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Colorectal Carcinoma — all drugs for Colorectal Carcinoma →
• Colorectal Adenoma — all drugs for Colorectal Adenoma →

Sponsor

University of Aarhus

Who can join

40 and older, any sex, with Colorectal Neoplasms or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Colorectal cancer (CRC) is one of the most common types of cancer in Denmark, and mortality among patients is high. Patients presenting with alarm symptoms of CRC are referred to colonoscopy in the cancer patient pathway for CRC. However, the proportion of patients with alarm symptoms who have CRC is below 10%. Simultaneously, the burden on endoscopy units to conduct fast-track colonoscopies is growing.

Occult blood in the faeces may be an early sign of cancer or precancerous lesions, and can be detected by an immunochemical faecal occult blood test (iFOBT). Few studies have examined the diagnostic properties of the iFOBT among symptomatic patients, and reported sensitivities ranging from 88%-100%, specificities from 77%-94%, and negative predictive values from 98%-100%. These results were derived from diverse patient populations, and used different cut-offs to define positive test results. Using iFOBT may be a valuable tool for the GP when deciding on referral of the patient to the cancer patient pathway. However, evidence is needed on the diagnostic accuracy of the test to detect CRC among patients presenting with alarm symptoms.

Hypothesis: In patients presenting with alarm symptoms of CRC, detection of faecal occult blood by iFOBT is an accurate measure of the presence of colonic lesions.

Aim: The aim of the study is to examine the diagnostic accuracy of the iFOBT among symptomatic patients referred to colonoscopy in the cancer patient pathway for CRC.

Materials and methods: The project is conducted as a diagnostic accuracy study. Patients appointed for colonoscopy will be invited to collect a faecal sample and mail it for analysis. The iFOBT result will be registered in a computer-based laboratory information system. The result of the colonoscopy will be registered in Danish national health registries. The sensitivity, specificity, positive predictive value and negative predictive value will be calculated as measures of the diagnostic properties of the iFOBT, using the result of colonoscopy as the reference standard. The accuracy of the test by type of alarm symptom will also be assessed.

Perspectives: The study will provide new and valuable data to evaluate the referral criteria for the cancer patient pathway. Given a good discriminatory ability of the iFOBT among symptomatic patients, fast-track colonoscopy may not be necessary as a first-choice examination in the diagnostic work-up of these patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.