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.

Study Type: Interventional

Study Design: Screening

Study Primary Completion Date: April 2014

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(s) in this Clinical Trial

• Other: diagnostic laboratory biomarker analysis
• Other: liquid chromatography
• Other: mass spectrometry
• Procedure: screening method

Primary Measures

• Validation of a new assay for lysophosphatidic acid (LPA)
  • Safety Issue?: No

Secondary Measures

• Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women
  • Safety Issue?: No
• LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer
  • Safety Issue?: No
• Response to primary adjuvant treatment and recurrence of disease
  • Safety Issue?: No
• Urine levels of CA125 and LPA at the time of surgery
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:
• Presenting to a gynecological oncologist with a unilateral or bilateral pelvic mass (defined as a simple, complex, or a solid ovarian/pelvic mass) and scheduled to undergo surgery
• Newly diagnosed epithelial ovarian cancer and undergoing first-line chemotherapy
• History of epithelial ovarian carcinoma status post-primary chemotherapy treatment, currently in clinical remission according to the following criteria:
• Absence of symptoms that may be related to disease
• Imaging without abnormalities ≥ 1 cm suspicious for disease (no ascites)
• CA125 obtained twice at least 3 weeks apart and not increasing by 50% and <
• 40 units/mL
• Known BRCA mutations and intact ovaries (no prior bilateral salpingo-oophorectomy)
• No synchronous primary endometrial cancer or a past history of primary endometrial cancer, unless all of the following conditions are met:
• Stage not greater than IB
• No more than superficial myometrial invasion, without vascular or lymphatic invasion
• No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
• No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
• Patients of any stage who have recurred and are in second chemotherapy induced remission are not eligible

PATIENT CHARACTERISTICS:

• Pre- or post-menopausal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other invasive malignancies within the past 5 years, with the exception of nonmelanoma skin cancer
• No septicemia, severe infection, or acute hepatitis

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radiotherapy to any portion of the abdominal cavity or pelvis
• No prior chemotherapy for another malignancy

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Women and Infants Hospital of Rhode Island

Overall Clinical Trial Officials and Contacts

Laurent Brard, MD, PhD, FACOG Principal Investigator Women and Infants Hospital of Rhode Island  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00986206

Study ID Number: CDR0000655148

ClinicalTrials.gov Identifier: NCT00986206

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database