Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

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.

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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 Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Scripps Clinic Carmel Valley, San Diego, California, 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
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

Treatment and study plan

Primary outcomes

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

Time frame: Blood draw within 30 days of surgery

Sponsors and collaborators

Lead sponsor

Fujirebio Diagnostics, Inc.

Industry

Collaborators

Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.

Registry information

Official study title

Evaluation of CA125 and HE4 Assays to Estimate the Risk of Ovarian Cancer in Patients Presenting to a General Surgeon or Obstetrician/Gynecologist With an Adnexal Mass

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Oct 1, 2009
Registry last updated: Feb 9, 2011

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