Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00986206|
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : January 5, 2018
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.
|Condition or disease||Intervention/treatment|
|brca1 Mutation Carrier brca2 Mutation Carrier Ovarian Cancer||Diagnostic Test: Biomarker LPA and HE4|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||525 participants|
|Official Title:||Development of an Assay for the Early Detection of Ovarian Cancer.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Collect serum for biomarker testing for LAP and HE4 and discovery of new biomarkers.
Diagnostic Test: Biomarker LPA and HE4
Non Interventional Trial
- Validation of a new assay for lysophosphatidic acid (LPA) [ Time Frame: 5 years ]To develop a serum or plasma based assay to quantitate LPA levels
- Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women [ Time Frame: 5 years ]To evaluate a quantitative serum LPA assay and correlate serum LPA levels in pre and post menopausal women with benign and malignant ovarian tumors.
- LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer [ Time Frame: 5 years ]To measure serum LPA levels in pre and postmenopausal women
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986206
|United States, Rhode Island|
|Women and Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Richard G Moore, MD||Women and Infants Hospital of Rhode Island|