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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT02451735
Eligibility Criteria:
Inclusion Criteria:
Part 1: Female breast cancer patients at Moffitt Cancer Center (MCC) are eligible to participate if they:
* are \> 18 years of age;
* have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis);
* are capable of speaking and reading standard English;
* have not attended or scheduled an upcoming appointment for genetic counseling at the time of recruitment;
* are within 18 months of their breast cancer (BC) diagnosis;
* have a previous diagnosis of breast cancer or;
* received a referral letter for GC from their MCC physician;
* breast cancer at age 50 or below;
* bilateral breast cancer;
* multiple cancers except basal cell carcinoma;
* triple negative breast cancer;
* ovarian cancer or fallopian tube cancer at any age;
* of Ashkenazi Jewish descent;
* have 2 or more blood relatives diagnosed with breast cancer;
* have any blood relatives diagnosed with bilateral breast cancer;
* a first degree relative diagnosed with breast cancer below age 50;
* have blood relatives diagnosed with ovarian cancer;
* have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer;
* have a known cancer gene mutation (such as BRCA 1/2;
* have any male relatives diagnosed with breast cancer ; and
* have a mailing address and working telephone number; and
* provide written informed consent.
Part 2: Female BC patients at MCC are eligible to participate if they:
* are \> 18 years of age;
* have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis);
* are capable of speaking and reading standard English;
* have not attended or scheduled an upcoming appointment for GC at the time of recruitment;
* have a previous diagnosis of breast cancer or;
* received a referral letter for GC from their MCC physician;
* breast cancer at age 50 or below;
* bilateral breast cancer;
* multiple cancers except basal cell carcinoma;
* triple negative breast cancer;
* ovarian cancer or fallopian tube cancer at any age
* of Ashkenazi Jewish descent;
* have 2 or more blood relatives diagnosed with breast cancer;
* have any blood relatives diagnosed with bilateral breast cancer;
* a first degree relative diagnosed with breast cancer below age 50;
* have blood relatives diagnosed with ovarian cancer;
* have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer;
* have a known cancer gene mutation (such as BRCA 1/2;
* have any male relatives diagnosed with breast cancer ; and
* have a mailing address and working telephone number; and
* provide written informed consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02451735
Study Brief:
Protocol Section:
NCT02451735