NCT01998009

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,382

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started May 2011

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

November 6, 2013

Last Update Submit

February 4, 2015

Conditions

Colorectal Cancer

Keywords

colorectal cancermass screeningfecal occult blood

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The proportion of participants with a negative colonoscopy finding who also have a negative fecal occult blood test result

    at time of colonoscopy

Study Arms (1)

Fecal occult blood tests

OTHER

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

Other: fecal occult blood tests

Interventions

fecal occult blood testsOTHER
Fecal occult blood tests

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University

Indianapolis, Indiana, United States

Location

University of Minnesota

Minneapolis, Minnesota, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 28, 2013

Study Start

May 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations

US(2)