Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

ClinicalTrials.gov ID: NCT00987649

Public ClinicalTrials.gov record NCT00987649. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00987649
Recruitment status: Completed
Study type: Observational
Phase: Not listed
Lead sponsor: Fujirebio Diagnostics, Inc.; Industry
Enrollment: 512 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2009 (Type not available)
Primary completion: Aug 2010 (Actual)
Completion: Sep 2010 (Actual)
Last update posted: Feb 9, 2011

2009 – 2010

United States locations

U.S. sites: 13
U.S. states: 10
U.S. cities: 13

Facility	City	State	ZIP	Site status
Scripps Clinic Carmel Valley	San Diego	California	92130	—
Women's Clinic of Northern Colorado	Fort Collins	Colorado	80524	—
OB/GYN Specialists of the Palm Beaches	Jupiter	Florida	33458	—
University of South Florida Medical Center	Tampa	Florida	33606	—
Woman's Hospital	Baton Rouge	Louisiana	70815	—
Weill Medical College of Cornell University	New York	New York	10021	—
New Hanover Regional Medical Center	Wilmington	North Carolina	28402	—
University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73110	—
Geisinger Medical Center	Danville	Pennsylvania	17822	—
Women & Infants Hospital Rhode Island	Providence	Rhode Island	02905	—
Chattanooga GYN-ONCOLOGY	Chattanooga	Tennessee	37403	—
Jackson Clinic	Jackson	Tennessee	38305	—
Adams Patterson Gynecology & Obstetrics	Memphis	Tennessee	38120	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00987649, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 9, 2011 · Synced Oct 21, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT00987649 live on ClinicalTrials.gov.

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