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NCT04487405 · ClinicalTrials.gov registry record
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
A clinical trial, sponsored by Aspira Women's Health.
- Terminated
- Registry status
- 721
- Enrollment target
NCT04487405: Clinical Trial study, sponsored by Aspira Women's Health.
NCT04487405 is a clinical trial that was terminated before completion, run by Aspira Women's Health. The registered enrollment target is 721 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04487405 was terminated before completion, sponsored by Aspira Women's Health.
- TERMINATED
- Registry status
- 721 participants
- Enrollment target
Study Summary
The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.
Primary Outcome
OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20.
Interventions
- DEVICE OVAnex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 721 participants |
| Start Date | 2020-06-25 |
| Est. Completion | 2023-12-15 |
Why NCT04487405 stopped before completion
NCT04487405 is an observational study that tracks outcomes without assigning an intervention. The registered 721 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which OVAnex is the first listed.
NCT04487405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04487405 about?
NCT04487405 is a clinical study titled "A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants". The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.
What is the current status of trial NCT04487405?
This trial is currently terminated. The enrollment target is 721 participants. The study started on 2020-06-25. Estimated completion is 2023-12-15.
What interventions are being tested in trial NCT04487405?
The interventions under investigation include: OVAnex (DEVICE).
Who is sponsoring clinical trial NCT04487405?
This trial is sponsored by Aspira Women's Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
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