Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT00017134
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Increased risk for ovarian cancer secondary to 1 of the following:
* Evidence of a BRCA1 or BRCA2 genetic mutation
* Family history of 1 or more first-degree relatives diagnosed with ovarian cancer prior to 50 years of age
* Family history of 1 first-degree relative with ovarian cancer (any age) AND 1 or more first- or second-degree relatives diagnosed with breast or ovarian cancer
* Personal history of breast cancer (at any age) AND 1 or more first- or second-degree relative diagnosed with breast or ovarian cancer at any age
* Meets any 1 of the following criteria:
* Ashkenazi Jewish ethnicity with 1 first-degree or 2 second-degree relatives with breast\* and/or ovarian cancer
* Ashkenazi Jewish ethnicity with diagnosed breast\* cancer in patient
* Greater than 20% probability of carrying BRCA1/2 mutation with a family history of breast and ovarian cancer NOTE: \* Where breast cancer is required to meet this criteria, diagnosis must occur prior to menopause or at ≤ 50 years old if age at menopause is unknown
* Planned prophylactic oophorectomy
* Normal pelvic exam within the past 6 weeks
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* GOG 0-1
Life expectancy:
* At least 12 months
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
* Triglyceride less than 2 times ULN (fasting)
Cardiovascular:
* No myocardial infarction within the past 3 months
* No active angina
* No unstable heart rhythms
* No clinically evident congestive heart failure
Other:
* No uncontrolled medical illness that would preclude study participation
* No uncontrolled diabetes
* No uncontrolled psychiatric illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 3 months since prior chemotherapy
Endocrine therapy:
* At least 3 months since prior hormonal therapy
* At least 8 weeks since prior hormone replacement therapy
* At least 8 weeks since prior oral, injectable, or implantable contraceptives
* No concurrent hormonal therapy, including hormone replacement therapy
Radiotherapy:
* At least 3 months since prior radiotherapy
* No prior radiotherapy to pelvis for malignancy
Surgery:
* See Disease Characteristics
Other:
* At least 3 months since prior investigational treatment
* No concurrent nutritional supplements except a daily multivitamin with less than 25,000 IU of vitamin A
* No prior non-steroidal anti-inflammatory drugs (NSAIDs) on a regular (chronic or daily) basis within the past 6 months
* No concurrent NSAIDs on a regular (chronic or daily) basis
* Concurrent aspirin at a dose of 81 mg/day allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00017134
Study Brief:
Protocol Section:
NCT00017134