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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT01292733
Eligibility Criteria:
Inclusion Criteria:
* Must meet one of the following:
* The family contains at least two ovarian or breast cancers in the subject or first or second degree relatives of the subject.
* The subject is of Ashkenazi Jewish ethnicity with one first degree or two second-degree relatives with breast or ovarian cancer, or subject is of Ashkenazi ancestry and has had breast cancer.
* The subject has a male relative with breast cancer diagnosed at any age.
* Probability of carrying a BRCA1/2 mutation given family pedigree of breast and ovarian cancers exceeds 20% (as determined by BRCAPRO 95% posterior probability interval).
Exclusion Criteria:
* Prior ovarian cancer or peritoneal carcinomatosis
* A first or second degree relative with a BRCA1/2 mutation and has tested negative for exactly the same mutation.
* The subject has no ovaries.
* Less than 30 years of age, unless 25-30 with BRCA I or II mutation confirmed
* Currently pregnant
* Currently receiving adjuvant chemotherapy or radiation therapy for cancer (excluding tamoxifen). Patients who are being treated for local disease may enroll 3 months after completion of last treatment (excluding tamoxifen).
* Treatment (excluding tamoxifen) for prior metastatic malignancy within the past five years.
* Intraperitoneal surgery within the last 3 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Study:
NCT01292733
Study Brief:
Protocol Section:
NCT01292733