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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT02993068
Eligibility Criteria:
Inclusion Criteria:
* Age 30 or older. Note: Participants must meet each of Criteria 1-4.
* Have access to a healthcare provider and be willing to share genetic results with that provider
* Have at least one ovary
* Have a valid United States mailing address for receipt of saliva kit
* Participants must meet any one of the following 6 criteria:
* Diagnosed with breast cancer at age 45 or younger
* Diagnosed with triple negative (negative for estrogen receptor, progesterone receptor and not human epidermal growth factor receptor 2 \[Her2\] amplified) breast cancer at 60 or younger
* Have one blood relative with a mutation in BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2
* Have one relative with ovarian cancer
* Have at least 2 relatives with breast cancer on the same side of the family, one of which is =\< 50 years of age
* Have one male relative with breast cancer
Exclusion Criteria:
* Personal history of ovarian cancer
* Unable to read, speak, and understand English
* Unable to provide informed consent
* Unwilling to complete baseline and follow-up questionnaires
* Unable to access the internet
* Previous genetic testing or counseling regarding cancer risk
* Previous bone marrow transplant
* Previous blood transfusion (7 days prior to genetic testing)
* Active hematologic malignancy (cancer that begins in blood-forming tissue, such as leukemia or lymphoma)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Study:
NCT02993068
Study Brief:
Protocol Section:
NCT02993068