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

Completed

Conditions studied: brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00986206

Run by

Women and Infants Hospital of Rhode Island

People needed

525

Starts

2009-06-01

Expected to finish

2015-07-01

Last updated by the study team

2018-01-05

Who can join

Age: 18 and older, up to 95. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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