Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer - Full Text View

Sponsor:	Women and Infants Hospital of Rhode Island
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00986206

Purpose

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.

Condition	Intervention
brca1 Mutation Carrier brca2 Mutation Carrier Ovarian Cancer	Other: diagnostic laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Procedure: screening method

Study Type:	Interventional
Study Design:	Primary Purpose: Screening
Official Title:	Development of an Assay for the Early Detection of Ovarian Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Validation of a new assay for lysophosphatidic acid (LPA) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women [ Designated as safety issue: No ]
LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer [ Designated as safety issue: No ]
Response to primary adjuvant treatment and recurrence of disease [ Designated as safety issue: No ]
Urine levels of CA125 and LPA at the time of surgery [ Designated as safety issue: No ]

Estimated Enrollment:	640
Study Start Date:	June 2009
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986206

Locations

United States, Rhode Island
Women and Infants Hospital of Rhode Island	Recruiting
Providence, Rhode Island, United States, 02905
Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122

Sponsors and Collaborators

Women and Infants Hospital of Rhode Island

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Laurent Brard, MD, PhD, FACOG

Women and Infants Hospital of Rhode Island

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurent Brard, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:	NCT00986206 History of Changes
Other Study ID Numbers:	CDR0000655148, WIHRI-09-0030
Study First Received:	September 26, 2009
Last Updated:	July 8, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 09, 2012