Status:

COMPLETED

Assess Cancer in Ovarian Tumors With Biomarkers.

Lead Sponsor:

Ciphergen Biosystems

Conditions:

Ovarian Tumor

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

Purpose The OvaRI assay clinical trial is directed at evaluating a novel proteomics-based blood test. This test is for a physician to use towards differentiating benign from malignant ovarian tumors ...

Detailed Description

Study Design This is a multi-center study including low and high prevalence ovarian cancer sites. The sites are representative of all institutions where potential ovarian tumor subjects will undergo a...

Eligibility Criteria

Inclusion

  • Subject is female and age 18 years or older
  • Subject has a level of understanding sufficient to agree to all tests required by the protocol, must be considered reliable and must be able to cooperate with study procedures
  • Subject signs approved written informed consent prior to any study procedures being performed
  • Subject must agree to venipuncture
  • Subject has a documented adnexal tumor with planned surgical intervention

Exclusion

  • Women under age 18
  • No planned surgical intervention
  • Decline phlebotomy
  • Diagnosis of malignancy in the last 10 years, with the exception of a non-melanoma skin cancer

Key Trial Info

Start Date :

February 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2008

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT00436189

Start Date

February 1 2007

End Date

April 1 2008

Last Update

April 30 2008

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Clinical Research Consultants

Hoover, Alabama, United States, 35216

2

Women's Health Research

Phoenix, Arizona, United States, 85015

3

Precision Trials

Phoenix, Arizona, United States, 85032

4

Gynecologic Oncology Associates

Newport Beach, California, United States, 92663