Maximizing Yield of the Fecal Immunochemical Test for Colorectal Cancer Screening

NCT01634126 | Completed Early Phase 1 DMC

• 2 other identifiers: 5R01CA1549821R01CA154982
• Study Type: interventional
• Target: 2,761
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is a leading cause of cancer death in the United States. Screening for CRC reduces CRC mortality, yet rates of screening in the United States remain low. Fecal occult blood testing (FOBT) has an established positive balance of benefit and risk, is the least expensive, and is the preferred method for nearly half of patients. A newer fecal screening test, the fecal immunochemical test (FIT), offers significant improvements over the FOBT. It is easier to use and is more sensitive at detecting both CRC and precancerous adenomas than the FOBT. The OC-Micro FIT is of particular interest because it is highly sensitive and specific and it is the only FIT test approved in the US that can be processed in an automated manner. Thus, the OC-Micro is an optimal method for use in mass screening programs to improve community CRC-screening rates. However, prior studies of OC-Micro suffer from several limitations: they were conducted in populations not optimal for assessing screening performance in average risk patients in the U.S. and the studies did not clearly establish optimal number of samples required and cut-points for test positivity. Therefore, the overall goal of MY-FIT is to capitalize on the highly integrated and extensive electronic medical record system of the study site to collect two separate sets of data that, when synthesized, will provide a thorough picture of the comparative patient adherence to, sensitivity, specificity, and costs of different protocols for using the OC-Micro FIT. Specifically, among KPNW members aged 50-75 who are at average risk for colorectal cancer (CRC) and who are due for CRC screening (n=78,000), the investigators propose to:

1. 1.Compare the sensitivity, specificity, positive predictive value, and negative predictive value for colorectal cancer and advanced adenoma (advanced neoplasia) between a single-sample FIT (1-FIT) and a two-sample FIT (2-FIT) using varying cut points for a positive test (n=2100).
2. 2.Compare patient adherence to completion of a 1-FIT versus a 2-FIT protocol (n=3000).
3. 3.Assess and compare cost per screen for a 1-FIT versus a 2-FIT protocol, and the cost per advanced neoplasia detected in a 1-FIT versus a 2-FIT protocol (using varying cut points for a positive test) (n=78,000).

Conditions

Colorectal Cancer

Keywords

Colon; Rectal; Cancer; Screening; FIT; Fecal

Outcome Measures

Primary Outcomes (1)

• FIT Kit adherence

  Among KPNW members aged 50-75 who are at average risk for colorectal cancer (CRC) and who are due for CRC screening, we propose to compare patient adherence to completion of a 1-FIT versus a 1-2 FIT protocol.

  Year 2 of study

Study Arms (2)

1 FIT kit

ACTIVE COMPARATOR

Behavioral: 1 FIT kit

2 FIT kit

ACTIVE COMPARATOR

Behavioral: 2 FIT kit

Interventions

1 FIT kit BEHAVIORAL

Patient receives 1 FIT

1 FIT kit

2 FIT kit BEHAVIORAL

Patient receives 2 FIT kits

2 FIT kit

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for standard KPNW automated telephonic colorectal cancer screening reminder and have indicated on the call that they wish to screen with FIT.

You may not qualify if:

• Kaiser Permanente members less than 1 year.
• Currently on the Kaiser Permanente Center for Health Research Do Not Call list.

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth G Liles, MD

  Kaiser Foundation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 16, 2016

Record last verified: 2016-09

Locations

US (1)