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fecal occult blood test

Louise Olsson, MD, PhD

The aim of this study is to compare the outcome of three (3) quantitative immunochemical faecal occult blood test in symptomatic patients.

Consecutive patients referred from primary care for colonoscopy due to symptoms are eligible. Patients will receive written information of the study together with the time for colonoscopy. A specific research nurse will call them and for those accepting participation, history and current medication will be collected. Kits will be sent to patients and they will provide three faecal samples before examination. These will be analysed at one certified laboratory.

Hemoglobin concentration will be notified in the range of 50 - \< 1000 ng/mL, or as a negative outcome.

Macroscopic findings at the colonoscopy will be collected, as well as the outcome of the pathological report.

Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients

Accuracy of diagnosis in colorectal cancer

Accuracy of diagnosis of colorectal polyps

Uppsala University

Each patient will perform one guaiac and two immunochemical fecal occult blood tests at home.

fecal occult blood tests

The objective of this study is to compare the performance characteristics or accuracy of different in-home screening tests for colorectal cancer (fecal occult blood tests), among patients without symptoms of colorectal cancer. Patients who meet study eligibility criteria and agree to participate in the study are asked to perform one guaiac and two immunochemical fecal occult blood tests at home prior to their colonoscopy. After the patient has completed and sent in the test kits, the patient then undergoes their previously scheduled colonoscopy. Accuracy and performance characteristics for each type of fecal occult blood test, including sensitivity, specificity, test positivity rate and positive predictive value for advanced colorectal neoplasia (advanced colorectal polyps) or colorectal cancer, will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.

One of the recommended options for colorectal cancer screening in the population at average risk for colorectal cancer is annual fecal occult blood test (FOBT) starting at age 50. Randomized controlled trials have shown that annual or biennial fecal occult blood testing using a guaiac-based test reduces incidence and mortality from colorectal cancer. However, the sensitivity and specificity of the guaiac-based tests is relatively low. Guaiac-based fecal tests can produce false-positive or false-negative results with certain foods, vitamins, or medications, so dietary restrictions are generally recommended before the test. Newer, immunochemical FOBTs use antibodies to detect the globin portion of human hemoglobin and do not require dietary restrictions. These immunochemical tests may have improved performance characteristics (sensitivity and specificity) compared with the guaiac-based tests. However, there have been few studies of the performance characteristics of the immunochemical tests in the average-risk population, particularly for the iFOBTs that are currently available in the U.S. There are several iFOBT tests on the U.S. market which may have different performance characteristics.

Some of the newer immunochemical tests also have the advantage of having a simpler sampling procedure for the patient. Guaiac-based FOBTs generally use sticks or spatulas to collect specimens from three stools that have not contacted toilet bowl water; these specimens are then smeared on test cards. However, some immunochemical tests allow sample collection by brushing the surface of the stool while it is in the toilet bowl water. In addition, some immunochemical tests only require samples from one or two stools.

Colorectal cancer is a leading cause of cancer-related morbidity and mortality. Key policy groups including the ACS, the American College of Radiology, the U.S. Multi-society Task Force on Colorectal Cancer, and the U.S. Preventive Services Task Force recommend the FOBT (guaiac or immunochemical-based) as one of several appropriate screening strategies for colorectal cancer. Although colonoscopy has higher sensitivity and specificity than FOBT in detecting advanced colorectal neoplasia, colonoscopy is an invasive test that has several potential disadvantages when screening the average-risk population, including higher costs, capacity limitations, and increased risk of complications. Immunochemical FOBT may have some advantages over both guaiac-based FOBT and colonoscopy for screening the average-risk population, including better performance characteristics and better patient acceptability than gFOBT and lower costs than colonoscopy. Unfortunately, the scientific literature on the sensitivity and specificity of the respective tests is not sufficient to support more specific recommendations about which test is best for routine screening among asymptomatic adults. This study will address that crucial gap in the literature.

Study of In-home Tests for Colorectal Cancer

Performance Characteristics of Immunochemical and Guaiac FOBT

This outcome will assess the sensitivity of the fecal occult blood test for detection of advanced colorectal neoplasia. Advanced colorectal neoplasia will be defined as an adenoma with a diameter of 10 mm or more, a villous adenoma, a tubulovillous adenoma, an adenoma with high-grade dysplasia, carcinoma in situ, or invasive cancer. For each type of fecal occult blood test, the sensitivity for advanced colorectal neoplasia will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.

This outcome will assess the specificity of the fecal occult blood test for detection of advanced colorectal neoplasia. Advanced colorectal neoplasia will be defined as an adenoma with a diameter of 10 mm or more, a villous adenoma, a tubulovillous adenoma, an adenoma with high-grade dysplasia, carcinoma in situ, or invasive cancer. For each type of fecal occult blood test, the specificity for advanced colorectal neoplasia will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.

Battelle Memorial Institute

University of Minnesota

Indiana University

Park Nicollet Health Services

Centers for Disease Control and Prevention

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.

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.

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

Qualitative fecal immunochemical test

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

Quantitative fecal immunochemical test

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

Colonoscopy

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

Cost analysis

Hospital Anxiety and Depression Scale (HADS) questionnaire

Anxiety scores

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

Patient satisfaction scores

April C Roslani, MBBCh

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).

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

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

Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm

Total costs incurred as a result of the screening process

As measured by the Hospital Anxiety and Depression Scale (HADS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients	NCT02491593	Colorectal Neop...	fecal occult bl...	18 Years -	Uppsala University
Quantitative Immunochemical Fecal Occult Blood Test in Symptomatic Patients	NCT02491593	Colorectal Neop...	fecal occult bl...	18 Years -	Uppsala University
Study of In-home Tests for Colorectal Cancer	NCT01998009	Colorectal Canc...	fecal occult bl...	50 Years - 75 Years	Centers for Disease Control and Prevention
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral	NCT02037646	Colorectal Canc...	Qualitative fec... Quantitative fe... Colonoscopy Cost analysis Anxiety scores Patient satisfa...	50 Years -	University of Malaya

Spots Global Cancer Trial Database for fecal occult blood