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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


N/A
18 Years
N/A
Not Enrolling
Female
Adnexal Mass, Ovarian Cancer

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

Blood draw within 30 days of surgery

Safety Issue:

No

Principal Investigator

Richard Moore, MD, FACOG, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Women & Infants Hospital Rhode Island

Authority:

United States: Institutional Review Board

Study ID:

FDI-15

NCT ID:

NCT00987649

Start Date:

October 2009

Completion Date:

September 2010

Related Keywords:

  • Adnexal Mass
  • Ovarian Cancer
  • pelvic mass
  • ovarian cancer
  • adnexal mass
  • CA125
  • HE4
  • Ovarian Neoplasms
  • Marfan Syndrome

Name

Location
Geisinger Medical Center Danville, Pennsylvania  17822-0001
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Weill Medical College of Cornell University New York, New York  10021
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Woman's Hospital Baton Rouge, Louisiana  70815
Chattanooga GYN-Oncology Chattanooga, Tennessee  37403
OB/GYN Specialists of the Palm Beaches West Palm Beach, Florida  33401
Scripps Clinic Carmel Valley San Diego, California  92130
Women's Clinic of Northern Colorado Fort Collins, Colorado  80524
University of South Florida Medical Center Tampa, Florida  33606
Women & Infants Hospital Rhode Island Providence, Rhode Island  02905
Jackson Clinic Jackson, Tennessee  38305
Adams Patterson Gynecology & Obstetrics Memphis, Tennessee  38120