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Development of an Assay for the Early Detection of Ovarian Cancer.

21 Years
Open (Enrolling)
brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer

Thank you

Trial Information

Development of an Assay for the Early Detection of Ovarian Cancer.



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


- 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.


- 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.

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.

Inclusion Criteria


- 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

- 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

- 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


- 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


- See Disease Characteristics

- No prior radiotherapy to any portion of the abdominal cavity or pelvis

- No prior chemotherapy for another malignancy

Type of Study:


Study Design:

Primary Purpose: Screening

Outcome Measure:

Validation of a new assay for lysophosphatidic acid (LPA)

Safety Issue:


Principal Investigator

Laurent Brard, MD, PhD, FACOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Women and Infants Hospital of Rhode Island



Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • brca1 Mutation Carrier
  • brca2 Mutation Carrier
  • Ovarian Cancer
  • 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
  • Ovarian Neoplasms



Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905