Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. To validate a new assay for lysophosphatidic acid (LPA) in early detection of ovarian cancer.

Secondary

1. 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

1. To examine the response to primary adjuvant treatment and recurrence of disease.
2. 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)

Entry Criteria

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

Prior/Concurrent Therapy:

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

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

Expected Enrollment

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.

Outcomes

Validation of a new assay for lysophosphatidic acid (LPA)

Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women
LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer
Response to primary adjuvant treatment and recurrence of disease
Urine levels of CA125 and LPA at the time of surgery

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.

Trial Contact Information

Trial Lead Organizations

Women and Infants Hospital of Rhode Island

Laurent Brard, MD, PhD, FACOG, Principal investigator		Ph: 401-453-7520

U.S.A.
Rhode Island
	Providence
	Women and Infants Hospital of Rhode Island
		Clinical Trials Office - Women and Infants Hospital of Rhode Island	Ph:  401-274-1122

Registry Information
Official Title		Development of an Assay for the Early Detection of Ovarian Cancer.
Trial Start Date		2009-06-01
Trial Completion Date		2014-04-01 (estimated)
Registered in ClinicalTrials.gov		NCT00986206
Date Submitted to PDQ		2009-09-14
Information Last Verified		2009-09-25
NCI Grant/Contract Number		CA136491

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