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

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.

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

Inclusion Criteria:

- Eligible Patients

- Patients age ≥ 21 years

- Patients with a diagnosis of a pelvic mass (defined as a simple, complex or a solid
ovarian / pelvic mass) who are scheduled to undergo surgery.

- Patients with a new diagnosis of epithelial ovarian carcinoma undergoing primary
chemotherapy treatment.

- Patients with a history of epithelial ovarian carcinoma status post primary
chemotherapy treatment, currently in clinical remission.

- Patients with a known BRCA mutation and who have NOT undergone a bilateral
salpingo-oophorectomy.

- Clinical remission should require all of following:

- Absence of symptoms that may be related to disease;

- Imaging without abnormalities greater then or equal to 1 cm suspicious for disease (no
ascites);

- CA 125 obtained x 2 at least 3 weeks apart and not increasing by 50% and < 40
units/mL.

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information.

- Women of childbearing potential must have a negative pregnancy test. They as well as
their partners must be willing to consent to using effective contraception while on
treatment and for a reasonable period thereafter.

Exclusion Criteria:

- Ineligible Patients

- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years. Patients with synchronous primary
endometrial cancer or a past history of primary endometrial cancer are excluded,
unless all of the following conditions are met: Stage not greater than I-B; 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.

- Patients with epithelial ovarian carcinoma of low malignant potential (Borderline
carcinomas).

- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis or have received chemotherapy for another malignancy.

- Patients of any stage who have recurred and are in second chemotherapy induced
remission.

- Patients with septicemia, severe infection, or acute hepatitis.

- Patients who are pregnant or lactating.