Status:
COMPLETED
Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
brca1 Mutation Carrier
brca2 Mutation Carrier
Eligibility:
FEMALE
18-95 years
Brief 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 us...
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 surger...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT00986206
Start Date
June 1 2009
End Date
July 1 2015
Last Update
January 5 2018
Active Locations (1)
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1
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905