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

2014-08-27 03:13:46 | BioPortfolio

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.

Description

Epithelial ovarian cancer (EOC) is usually lethal unless it is diagnosed at an early stage, thus early detection is likely to play an important role in reducing its mortality. Within the Ovarian Specialized Programs of Research Excellence Pacific Ovarian Cancer Research Consortium (POCRC) researchers have been working for a decade to discover, develop, and validate biomarkers (proteins or substances found in blood) that could help save lives by detecting EOC early. During the last five years several biomarkers, including CA125, have been evaluated for their ability to detect EOC at an earlier stage. The best markers will now be studied in a new randomized controlled trial of ovarian cancer screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Conditions

Epithelial Ovarian Cancer

Intervention

CA125 assay on Abbott Architect i1000SR platform, HE4 assay on Architect i1000SR platform, Transvaginal Ultrasound

Location

City of Hope
Duarte
California
United States
91010

Status

Recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:46-0400

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