Last reviewed · How we verify
NCT04487405: OVAnex
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
trial testing OVAnex in Adnexal Mass in 721 participants. Terminated before completion.
15 December 2023
Quick facts
| Lead sponsor | Aspira Women's Health |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 721 |
| Start date | 25 June 2020 |
| Primary completion | 15 December 2023 |
| Estimated completion | 15 December 2023 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- OVAnex
Conditions studied
- Adnexal Mass — all drugs for Adnexal Mass →
Sponsor
Aspira Women's Health
Who can join
18 and older, female only, with Adnexal Mass. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Diagnostic biomarkers in ovarian cancer: advances beyond CA125 and HE4.
Ghose A, McCann L, Makker S, Mukherjee U, et al · · 2024 · cited 75× · PMID 38435431 · DOI 10.1177/17588359241233225
Verify or expand the search:
- PubMed search for NCT04487405
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Adnexal Mass
Currently open trials in the same condition.
- NCT06693596 — Masses in Young Patients - International Ovarian Tumour Analysis (MY-IOTA) · recruiting
- NCT05761275 — Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach · NA · recruiting
- NCT05051722 — Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer · recruiting
Other Aspira Women's Health trials
Trials by the same sponsor.
- NCT05245695 — Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck) · recruiting
- NCT04668521 — Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04487405 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aspira Women's Health
- Last refreshed: 26 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04487405.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing