New Biomarkers Evaluating Ovarian Cancer

Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01466049

Enrollment

280

Registered

2011-11-07

Start date

2011-12-31

Completion date

2014-03-31

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adnexal Mass

Keywords

Ovarian Cancer, Adnexal Mass, Pelvic Mass

Brief summary

The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female, age 18 years or older * Adnexal mass present documented by imaging * Scheduled to undergo surgery based on a finding of adnexal mass * Able 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
Evaluate novel biomarkers for patients with an adnexal mass	observational studies

Countries

United States

Outcome results