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NCT01052922 · ClinicalTrials.gov registry record · NA
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 2,260
- Enrollment target
NCT01052922 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 2,260 participants.
The verdict
NCT01052922, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,260 participants
- Enrollment target
Study Summary
Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the first time since randomization to have CRCS, either based on FOBT, FS, or CS. Knowing screening rates will not only enable us to make comparisons between groups, but also over time. Ancillary Aims #2 and #3 We will recruit additional participants for two ancillary study aims. First, we will enroll patients age 50-74 years using the same criteria as for the primary SOS study, which includes neither history of colorectal cancer nor evidence of life-limiting disease. Participants who return the questionnaire, consent and considered eligible will be randomized to receive one of three different at-home fecal test kits. The kits will be returned to the GH centralized laboratory, and participants will be informed about lab results using standard GH pathways. Participants who have a test-positive will receive a series of two follow-up surveys (first at 1-2 weeks post result and second at 4-months post result). A comparison group of test-negative results will be matched based on selected criteria, and this group will also receive the follow-up surveys. Participants at both time intervals who do not return the survey via mail will be called and if available, administered the questionnaire via phone.
Interventions
- OTHER 3 sample g-SENSA
- OTHER 2 sample InSure
- OTHER 1 sample OC-Micron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,260 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01052922
The ClinicalTrials.gov registry entry for NCT01052922 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,260 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 3 interventions - of which 3 sample g-SENSA is the first listed.
NCT01052922 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01052922 about?
NCT01052922 is a clinical study titled "Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up Supplement". Ancillary Aim #1 We will evaluate intervention effects by comparing binary outcomes for screening (yes/no) in the primary SOS study. In this aim, we propose to calculate actual screening rates by use of time-to-event analyses (also known as survival analysis). The outcome variable of interest is the...
What is the current status of trial NCT01052922?
This trial is currently completed. It is a NA study. The enrollment target is 2,260 participants. The study started on 2009-08. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01052922?
The interventions under investigation include: 3 sample g-SENSA (OTHER), 2 sample InSure (OTHER), 1 sample OC-Micron (OTHER).
Who is sponsoring clinical trial NCT01052922?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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