Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
Condition: brca1 Mutation Carrier; brca2 Mutation Carrier; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

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.
    

Intervention name(s): Biomarker LPA and HE4
Intervention type(s): Diagnostic Test
Intervention description(s): Non Interventional Trial
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women presenting with a pelvic mass and scheduled to undergo surgery.
      
Biospecimen description: 
      Serum, Plasma, Urine
    
Keywords: ovarian epithelial cancer; BRCA1 mutation carrier; BRCA2 mutation carrier; stage IA ovarian epithelial cancer; stage IB ovarian epithelial cancer; stage IC ovarian epithelial cancer; stage IIA ovarian epithelial cancer; stage IIB ovarian epithelial cancer; stage IIC ovarian epithelial cancer; stage IIIA ovarian epithelial cancer; stage IIIB ovarian epithelial cancer; stage IIIC ovarian epithelial cancer; stage IV ovarian epithelial cancer