New Biomarkers Evaluating Ovarian Cancer

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.

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Key information

Conditions

Adnexal Mass Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

New Hanover Regional Medical Center, Wilmington, North Carolina, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Evaluate novel biomarkers for patients with an adnexal mass

Time frame: observational studies

Sponsors and collaborators

Lead sponsor

Fujirebio Diagnostics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Nov 7, 2011
Registry last updated: Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed