Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
Conditions
brca1 Mutation Carrier - brca2 Mutation Carrier - Ovarian Cancer
Conditions: official terms
Ovarian Neoplasms
Conditions: 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
Study Type
Interventional
Study Phase
N/A
Study Design
Primary Purpose: Screening
Intervention
Name: diagnostic laboratory biomarker analysis Type: Other
Name: liquid chromatography Type: Other
Name: mass spectrometry Type: Other
Name: screening method Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Female
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

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
Location
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Status: Recruiting
Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I - 401-274-1122
Start Date
June 2009
Sponsors
Women and Infants Hospital of Rhode Island
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page