Adnexal Mass, Ovarian Cancer
Conditions
Keywords
pelvic mass, ovarian cancer, adnexal mass, CA125, HE4
Brief summary
The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to remove a pelvic mass. After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood sample will be collected within 30 days of the surgical procedure. Results of the surgical procedure will be collected and analyzed against the CA125 and HE4 results used in the calculation of the ROMA.
Interventions
None listed
Sponsors
Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.
Fujirebio Diagnostics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female, age ≥ 18 years * Adnexal mass present documented by imaging * Scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis) * Able to understand and willing to provide Informed Consent
Exclusion criteria
* Previous history of ovarian cancer * Previous history of bilateral oophorectomy * Currently known to be pregnant * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone | Blood draw within 30 days of surgery |
Countries
United States
Outcome results
None listed