NCT01121640

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 854 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Female
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-11-01
• Primary completion: 2015-05-07
• Completion: 2015-05-07
• First posted: 2010-05-12
• Last updated: 2018-12-13

Locations

5 sites across 1 country: United States