A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
Public ClinicalTrials.gov record NCT01121640. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Controlled Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01121640
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 854 participants
Conditions and interventions
Conditions
Interventions
- CA125 assay on Abbott Architect i1000SR platform Procedure
- HE4 assay on Architect i1000SR platform Procedure
- Transvaginal Ultrasound Procedure
Procedure
Eligibility (public fields only)
- Age range
- 25 Years to 80 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2009
- Primary completion
- May 6, 2015
- Completion
- May 6, 2015
- Last update posted
- Dec 12, 2018
2009 – 2015
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Stanford University | Stanford | California | 94305 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01121640, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 12, 2018 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01121640 live on ClinicalTrials.gov.