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NCT01634126 · ClinicalTrials.gov registry record · Early Phase 1
Maximizing Yield of the Fecal Immunochemical Test for Colorectal Cancer Screening
A Early Phase 1 study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 2,761
- Enrollment target
NCT01634126 is a Early Phase 1 study that has completed, run by Kaiser Permanente. The registered enrollment target is 2,761 participants.
The verdict
NCT01634126, a Early Phase 1 study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 2,761 participants
- Enrollment target
Study 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. 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. Compare p
Interventions
- BEHAVIORAL 1 FIT kit
- BEHAVIORAL 2 FIT kit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,761 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-04 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01634126
The ClinicalTrials.gov registry entry for NCT01634126 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 2,761 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 1 FIT kit is the first listed.
NCT01634126 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01634126 about?
NCT01634126 is a clinical study titled "Maximizing Yield of the Fecal Immunochemical Test for Colorectal Cancer Screening". 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 ...
What is the current status of trial NCT01634126?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 2,761 participants. The study started on 2012-08. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01634126?
The interventions under investigation include: 1 FIT kit (BEHAVIORAL), 2 FIT kit (BEHAVIORAL).
Who is sponsoring clinical trial NCT01634126?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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