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

NCT02785731CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Angle plc

Enrollment

204

Start Date

2016-07-14

Completion Date

2017-10-09

Study Type

OBSERVATIONAL

Official Title

ANG-001 Pelvic Mass Training Study: Evaluation of Multiple Circulating Tumor Cell-derived RNA Markers to Estimate Risk of Ovarian Cancer in Patients Presenting With a Pelvic Mass.

Interventions

Pelvic imagingBlood drawlaparotomy or laparoscopy

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Women \>18 years of age;
* Documented evidence of a pelvic mass by imaging;
* Selected to undergo laparotomy or laparoscopy based on the finding of a pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass);
* Willing and able to provide written informed consent prior to the blood collection.
* Suitable venous access and healthy enough (as determined by the treating physician) to provide required whole blood sample.

Exclusion Criteria:

* Known pregnancy;
* Subjects receiving cytotoxic chemotherapies;
* Previous malignancy within the past 5 years, excluding skin cancers (squamous cell or basal cell);
* Unwilling or unable to follow protocol requirements or to provide informed consent.

Outcome Measures

Primary Outcomes

Histopathological diagnosis

Tissue samples taken from the pelvic mass will be evaluated in the local institutional pathology department according to institutional guidelines. Results from the histopathological evaluation, including the final diagnosis (i.e. benign, malignant, etc.), histopathology description, and, if malignant, clinical or surgical staging and tumor subtype, will be recorded.

Time frame: Within 30 days after biopsy or surgical procedure to evaluate pelvic mass

Presence or absence of circulating tumor cells

Blood from EDTA tubes will be pooled and processed on the Parsortix System to capture and harvest rare cells. The captured rare cells will be eluted (harvested) and lysed, and total RNA will be extracted from the cell lysate for evaluation of multiple gene targets using quantitative PCR (qPCR).

Time frame: Up to 60 days prior to surgical procedure to evaluate pelvic mass

Serum protein markers

Serum from SST tube will be used for protein biomarker testing.

Time frame: Up to 60 days prior to surgical procedure to evaluate pelvic mass

Locations

Medical University of Vienna, Vienna, Austria

Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany

Vivantes-Klinikum Neukölln, Berlin, Germany

Charité - Universitätsmedizin Berlin, Berlin, Germany

Vivantes Humboldt-Klinikum, Berlin, Germany

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

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