Study of In-home Tests for Colorectal Cancer (SIT)

Performance Characteristics of Immunochemical and Guaiac FOBT

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: fecal occult blood tests

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 1382
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States
      • Indiana University
  • Minnesota
    • Minneapolis, Minnesota, United States
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 50 - 75 years of age
• Scheduled to have a colonoscopy for screening or as a routine exam
• Has not had more than one episode of rectal bleeding in the last 6 months
• Does not have a personal history of colorectal cancer or colorectal polyps
• Has not had a positive FOBT in the 12 months prior to study enrollment
• Has not had a colonoscopy within the past 5 years
• Has not had a prior colon resection or colon or rectal surgery
• Does not have a history of inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease)
• Does not have a personal or family history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
• Not currently taking anticoagulant medication such as Coumadin, Warfarin, Heparin, or Plavix
• Able to read English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fecal occult blood tests; Each patient will perform one guaiac and two immunochemical fecal occult blood tests at home.	Other: fecal occult blood tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with a positive colonoscopy finding indicating an advanced colorectal neoplasia who also have a positive fecal occult blood test result	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.	at time of colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with a negative colonoscopy finding who also have a negative fecal occult blood test result	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.	at time of colonoscopy

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Collaborators: University of Minnesota; Indiana University; Battelle Memorial Institute; Park Nicollet Health Services

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: colorectal cancer; mass screening; fecal occult blood
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CDC-NCCDPHP-5985