Evaluation of Multiple Biomarkers to Estimate Risk of Ovarian Cancer in Patients With a Pelvic Mass.

Summary

ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system capable of harvesting rare circulating cells for analysis from a sample of peripheral blood based on cellular size and deformability. In a small pilot study, scientists at the Medical University of Vienna demonstrated that measurement of a combination of mRNA markers extracted from CTCs captured using the Parsortix system could be used to identify women with ovarian cancer. This study is designed to provide specimens for optimization of an assay using clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor markers) in combination with mRNA extracted from rare cells in the blood of women presenting with a pelvic mass for the detection of malignancy.

Primary Objective: Optimization of an assay for the differentiation of women with benign pelvic masses from those with malignant pelvic masses using mRNA markers extracted from CTCs isolated from whole blood. Multiple serum tumor markers and mRNA markers will be measured, and the results will be compared to the actual clinical diagnosis made for each patient through other recognized methods (e.g. histopathology). The blood samples collected in the course of this study will be used to finalize the selection of mRNA and/or serum tumor markers to be evaluated in future prospective studies.

Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary design of a mathematical algorithm to combine the multiple serum tumor and/or mRNA markers for estimation of the risk of ovarian cancer.

Conditions

• Ovarian Neoplasms

Interventions

PROCEDURE

Pelvic imaging

Within 60 days prior to the pelvic mass evaluation procedure, each subject must have a pelvic imaging study (e.g. ultrasound, CT scan, MRI, etc.) conducted and read to visualize the pelvic mass according to the current standard of care. Results of the pelvic imaging study(ies) will be recorded.

PROCEDURE

Blood draw

Within 60 days prior to, or on the day of the pelvic mass surgery, collect up to 35mL of whole blood into one 5mL SST tube, which must be drawn first, followed by three separate 10mL EDTA tubes.

PROCEDURE

laparotomy or laparoscopy

A laparotomy or laparoscopic procedure will be performed by a qualified individual for excision of the pelvic mass. Representative tissue samples will be taken from the excised pelvic mass and evaluated in pathology departments within each institution according to institutional guidelines. Results from the histopathological evaluation will be recorded, including the final diagnosis along with histological sub-type, and if available, stage and grade of cancer where disease is identified.

Sponsors & Collaborators

• Medical University of Vienna

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Vivantes Netzwerk für Gesundheit GmbH

  collaborator OTHER

• Angle plc

  lead INDUSTRY

Principal Investigators

• Shane Booth, Ph.D. · Angle plc

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-14

Primary Completion

2017-10-09

Completion

2018-07-31

Countries

• Austria
• Germany

Study Locations