Study Stopped
cohort C looked at feasibility of genetics \& protein to evaluate risk with a family hx of cancer or associated variant. Since few patients show these factors, this approach would not yield sufficient information to make inferences
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
OVAnex
1 other identifier
observational
721
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 2020
CompletedFirst Submitted
Initial submission to the registry
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedDecember 26, 2023
December 1, 2023
3.5 years
July 10, 2020
December 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
OVAnex
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.
12 months
Study Arms (3)
Group A
Symptomatic with adnexal mass
Group B
Asymptomatic with adnexal mass
Group C
Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant
Interventions
Eligibility Criteria
Adult women with an ovarian adnexal mass, or in follow up due to the presence of BRCA1/2 and other germline DNA variants.
You may qualify if:
- Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.
- Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.
You may not qualify if:
- Patient is less than 18 years of age
- Patient is not being treated in the U.S.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Women's Health Arizona
Chandler, Arizona, 85224, United States
Altus Research
Lake Worth, Florida, 33461, United States
MidTown OBGYN
Columbus, Georgia, 31901, United States
Premier OBGYN of Minnesota
Eden Prairie, Minnesota, 55344, United States
Square Care Health
New Hyde Park, New York, 11040, United States
Northwell Health
New Hyde Park, New York, 11042, United States
Seven Hills Clinical Research Group
Cincinnati, Ohio, 45211, United States
May Grant OB/GYN
Lancaster, Pennsylvania, 17601, United States
Hill Country OBGYN Associates
Austin, Texas, 78748, United States
Biospecimen
Serum
Study Officials
- PRINCIPAL INVESTIGATOR
Todd Pappas, PhD
Aspira Women's Health
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2020
First Posted
July 27, 2020
Study Start
June 25, 2020
Primary Completion
December 15, 2023
Study Completion
December 15, 2023
Last Updated
December 26, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share