Ovarian Cancer Clinical Trial
Official title:
Development of an Assay for the Early Detection of Ovarian Cancer.
RATIONALE: Screening tests, such as the lysophosphatidic acid assay, may help doctors find
cancer cells early and plan better treatment for ovarian cancer.
PURPOSE: This clinical trial is studying using the lysophosphatidic acid assay to see how
well it works in early detection of ovarian cancer in patients with ovarian cancer or who are
at risk for ovarian cancer.
OBJECTIVES:
Primary
- To validate a new assay for lysophosphatidic acid (LPA) in early detection of ovarian
cancer.
Secondary
- To estimate the risk of finding ovarian cancer at the time of surgery in pre- and
post-menopausal women presenting with a pelvic mass and compare LPA results from both
surgical patient groups with those from "normal", disease-free women at high-risk of
ovarian cancer.
Tertiary
- To examine the response to primary adjuvant treatment and recurrence of disease.
- To evaluate urine levels of CA125 and LPA to determine their ability to estimate the
risk of cancer at the time of surgery in patients presenting with a pelvic mass.
(exploratory)
OUTLINE: Blood and urine samples are collected before or on the day of surgery; before,
during, and after completing chemotherapy; or at a clinic visit. Samples are tested for
concentrations of CA125 and lysophosphatidic acid (LPA) using a new assay and compared to
liquid chromatography/electrospray ionization-tandem mass spectrometry results. Remaining
serum, plasma, and urine is stored frozen for future research evaluation of other novel
biomarkers for the diagnosis and prognosis of cancer.
After completion of study, patients are followed up periodically for approximately 5 years.
PROJECTED ACCRUAL: A total of 500 surgical patients, 100 cancer patients undergoing
first-line therapy, and 40 disease-free women who are known BRCA-mutation carriers will be
accrued for this study.
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