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:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT00582803
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 25 years or greater
* Genetic predisposition as defined by one of the following:
* Known BRCA1 or BRCA2 mutation (deleterious or uncertain significance) OR
* Untested first-degree relative of an individual with a known deleterious BRCA mutation OR
* Unaffected first-degree relative of an affected individual within a hereditary breast-ovarian kindred in which no testing has been performed or testing is negative, defined as: 3 or more women in 2 generations affected with breast or ovarian cancer. Women with bilateral breast cancer and woman with both breast and ovarian cancer count as single individual AND 1 woman must be first-degree relative of the other two, or related to the other two through a male AND At least 1 woman affected with breast cancer before age 50 or ovarian cancer at any age
* Able to understand and complete English-language questionnaires
* Intend to receive clinical and radiographic follow-up at MSKCC
* Women will not be excluded if they have previously received clinical and radiographic follow-up at either MSKCC or another institution.
Exclusion Criteria:
* Prior history of breast or ovarian cancer
* Contraindication to breast MRI examination (e.g. aneurysm clips, pacemaker, cochlear implant, severe claustrophobia, weight over 300 pounds) or to paramagnetic contrast (prior IgE-type allergic reaction, sickle cell anemia, renal failure)
* Pregnant or planning to begin attempts at conception within 1 year of enrollment. A negative serum β-hCG will not be required for study entry, nor for radiographic examination, as this test is not routinely performed before clinically indicated radiographic study.
* Unable for physical, psychological, or financial reasons to receive clinical and radiographic follow-up at MSKCC
* Concurrent medical or psychological conditions that, in the opinion of the attending physician or Principal Investigator, would place the subject at risk were she to participate
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Study:
NCT00582803
Study Brief:
Protocol Section:
NCT00582803