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NCT01998009 · ClinicalTrials.gov registry record · NA
Study of In-home Tests for Colorectal Cancer
A NA study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- NA
- Development phase
- 1,382
- Enrollment target
NCT01998009: Completed NA study, sponsored by Centers for Disease Control and Prevention.
NCT01998009 is a NA study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 1,382 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01998009, a NA study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,382 participants
- Enrollment target
Study 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.
Primary Outcome
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 t
Interventions
- OTHER fecal occult blood tests
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,382 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-09 |
| Phase | NA |
What the finished NCT01998009 record still lists
NCT01998009 is an interventional study that assigns participants to a tested intervention. Its 1,382 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which fecal occult blood tests is the first listed.
NCT01998009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01998009 about?
NCT01998009 is a clinical study titled "Study of In-home Tests for Colorectal Cancer". 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 ...
What is the current status of trial NCT01998009?
This trial is currently completed. It is a NA study. The enrollment target is 1,382 participants. The study started on 2011-05. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01998009?
The interventions under investigation include: fecal occult blood tests (OTHER).
Who is sponsoring clinical trial NCT01998009?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01998009's enrollment target sits among peer trials
1,382 73rd of 2000 higher than 1,928 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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