A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women

Summary

The Novel Markers Trial will compare the safety, feasibility and effectiveness of two different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either a first or second line screen. This study is the next step in a larger research effort to develop a blood test that can be used as a screening method for the early detection of epithelial ovarian cancer.

Conditions

• Epithelial Ovarian Cancer

Interventions

PROCEDURE

CA125 assay on Abbott Architect i1000SR platform

Bead-based sandwich ELISA style assay

PROCEDURE

HE4 assay on Architect i1000SR platform

Bead-based sandwich ELISA style assay

PROCEDURE

Transvaginal Ultrasound

Sonogram will be obtained only if confirmatory markers are elevated. Exam is restricted to ovarian evaluation.

Sponsors & Collaborators

• The Marsha Rivkin Center for Ovarian Cancer Research

  collaborator OTHER

• Canary Foundation

  collaborator OTHER

• Swedish Medical Center

  collaborator OTHER

• City of Hope Medical Center

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Fox Chase Cancer Center

  collaborator OTHER

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Nicole Urban, ScD · Fred Hutchinson Cancer Center

• Beth Karlan, MD · Cedars-Sinai Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2015-05-07

Completion

2015-05-07

Countries

• United States

Study Locations