Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
Recruitment status was: Recruiting
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.
brca1 Mutation Carrier
brca2 Mutation Carrier
Other: diagnostic laboratory biomarker analysis
Other: liquid chromatography
Other: mass spectrometry
Procedure: screening method
|Study Design:||Primary Purpose: Screening|
|Official Title:||Development of an Assay for the Early Detection of Ovarian Cancer.|
- Validation of a new assay for lysophosphatidic acid (LPA) [ Designated as safety issue: No ]
- Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women [ Designated as safety issue: No ]
- LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer [ Designated as safety issue: No ]
- Response to primary adjuvant treatment and recurrence of disease [ Designated as safety issue: No ]
- Urine levels of CA125 and LPA at the time of surgery [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
- To validate a new assay for lysophosphatidic acid (LPA) in early detection of ovarian cancer.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986206
|United States, Rhode Island|
|Women and Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Laurent Brard, MD, PhD, FACOG||Women and Infants Hospital of Rhode Island|