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NCT01121640 · ClinicalTrials.gov registry record · NA
A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
A NA study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 854
- Enrollment target
NCT01121640: Completed NA study, sponsored by Fred Hutchinson Cancer Center.
NCT01121640 is a NA study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 854 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01121640, a NA study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 854 participants
- Enrollment target
Study Summary
The Novel Markers Trial will compare the safety, feasibility and effectiveness of two different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either a first or second line screen. This study is the next step in a larger research effort to develop a blood test that can be used as a screening method for the early detection of epithelial ovarian cancer.
Primary Outcome
Calculated as number of women with a significant lesion identified at a protocol-indicated procedure divided by number of women with protocol-indicated surgical procedures performed.
Interventions
- PROCEDURE Transvaginal Ultrasound
- PROCEDURE CA125 assay on Abbott Architect i1000SR platform
- PROCEDURE HE4 assay on Architect i1000SR platform
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 854 participants |
| Start Date | 2009-11 |
| Est. Completion | 2015-05-07 |
| Phase | NA |
What the finished NCT01121640 record still lists
NCT01121640 is an interventional study that assigns participants to a tested intervention. The registered 854 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 3 interventions - of which Transvaginal Ultrasound is the first listed.
NCT01121640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01121640 about?
NCT01121640 is a clinical study titled "A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women". The Novel Markers Trial will compare the safety, feasibility and effectiveness of two different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either a first or second line screen. This study is the next step in a larger research effort to develop a blood test that can ...
What is the current status of trial NCT01121640?
This trial is currently completed. It is a NA study. The enrollment target is 854 participants. The study started on 2009-11. Estimated completion is 2015-05-07.
What interventions are being tested in trial NCT01121640?
The interventions under investigation include: Transvaginal Ultrasound (PROCEDURE), CA125 assay on Abbott Architect i1000SR platform (PROCEDURE), HE4 assay on Architect i1000SR platform (PROCEDURE).
Who is sponsoring clinical trial NCT01121640?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01121640's enrollment target sits among peer trials
854 131st of 2000 higher than 1,870 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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