Trial Information

Evaluation of a Multiple Biomarker Assay to Estimate the Risk of Ovarian Cancer in Patients Presenting With a Pelvic Mass.

The Pelvic Mass study is a prospective, multi-center, double blind, statistically powered
clinical trial that will enroll female subjects ≥18 years of age presenting to a
gynecologist or gynecological oncologist with a pelvic mass (defined as a simple, complex or
a solid ovarian cyst / pelvic mass) who are scheduled to undergo surgery.

The serum tumor marker CA125 has been the most widely used marker in ovarian cancer,
however, it is not sufficiently sensitive or specific for the detection of early stage
disease. The levels of soluble mesothelin related peptides (SMRP) and HE4 have also
recently been found to be elevated in women with ovarian cancer. The results of a pilot
study suggest that the use of HE4 may improve the sensitivity of CA125 and provide for
stratification of patients presenting with a pelvic mass into high, intermediate and low
risk groups.

HE4 and CA125 serum levels will be evaluated in this study for their ability to stratify
patients presenting with a pelvic mass into risk groups with low, intermediate or high
probabilities of harboring an ovarian cancer at the time of initial presentation. The
algorithm using these two serum markers to stratify patients that was developed using pilot
study data will be evaluated in this prospective multicenter pelvic mass study. We will
also evaluate the inclusion of additional biomarkers and risk factors, such as ultrasound
score, age, and menopausal status, into the algorithm to see if there is any improvement in
the stratification of patients into the risk groups.

The primary objective of the study is to estimate the risk of finding ovarian cancer at the
time of surgery in pre- and post-menopausal women presenting with pelvic mass. Multiple
serum biomarkers (CA125 and HE4) will be evaluated to estimate the risk that the patient is
harboring an ovarian cancer at the time of presentation.

The secondary objective of the study is to develop a multivariate predictive algorithm
combining CA125 and HE4 with radiological imaging results, and patient risk factors (such as
age, menopausal status and ethnicity) to estimate the risk of ovarian cancer, including low
malignant potential (LMP) / borderline tumors, at the time of surgery in patients presenting
with a pelvic mass.

The exploratory endpoints will include the evaluation of serum, plasma and/or urine levels
of CA125, HE4 and other additional novel biomarkers such as SMRP, alone and in combination
with radiological imaging results and subject risk factors to determine their ability to
estimate the risk of cancer at the time of surgery in patients presenting with a pelvic
mass.