NCT00986206

Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer

Development of an Assay for the Early Detection of Ovarian Cancer.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 525 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• brca1 Mutation Carrier
• brca2 Mutation Carrier
• Ovarian Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biomarker LPA and HE4	Non Interventional Trial

Timeline

• Start date: 2009-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2009-09-29
• Last updated: 2018-01-05

Locations

1 site across 1 country: United States