Healthy | Gender | Age | Availability of Specimen Bilateral
Item
1. healthy, female, age 20-75 years, from whom bi-lateral specimens can be obtained.
boolean
C3898900 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0470187 (UMLS CUI [4,1])
C0370003 (UMLS CUI [4,2])
C0238767 (UMLS CUI [4,3])
Gender | Nipple Aspirate Fluid Cytology test Favorable
Item
2. any woman for whom naf cytology testing is considered to be beneficial by her physician.
boolean
C0079399 (UMLS CUI [1])
C2717761 (UMLS CUI [2,1])
C1305671 (UMLS CUI [2,2])
C3640814 (UMLS CUI [2,3])
Breast Feeding Absent | Pregnancy Absent | Postmenopausal state
Item
3. non-lactating and non-pregnant (as documented by date of last menstrual period or post-menopausal).
boolean
C0006147 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
General health good | Determined by Medical History | Determined by Breast Disease History | Determined by History of cancer | Determined by Examination of breast
Item
4. good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.
boolean
C1277245 (UMLS CUI [1])
C0521095 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0521095 (UMLS CUI [3,1])
C0006145 (UMLS CUI [3,2])
C0262926 (UMLS CUI [3,3])
C0521095 (UMLS CUI [4,1])
C0455471 (UMLS CUI [4,2])
C0521095 (UMLS CUI [5,1])
C0199850 (UMLS CUI [5,2])
Informed Consent | Protocol Compliance
Item
5. willing to give informed consent and follow study procedures as directed.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Medical condition Study Subject Participation Status Poor | Mental condition Study Subject Participation Status Poor
Item
1. medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the principal investigator.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2700379 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2700379 (UMLS CUI [2,3])
Pregnancy | Suspicion Pregnancy
Item
2. pregnancy or suspicion of pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
Open wound Cutaneous | Atopic Dermatitis Area Areola of nipple
Item
3. open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.
boolean
C0332798 (UMLS CUI [1,1])
C0221912 (UMLS CUI [1,2])
C0011615 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C0149537 (UMLS CUI [2,3])
Nipple Lacking | Inversion of nipple | Prior surgery Area Areola of nipple
Item
4. no or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.
boolean
C0028109 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0269269 (UMLS CUI [2])
C0455610 (UMLS CUI [3,1])
C0205146 (UMLS CUI [3,2])
C0149537 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
5. participation in an investigational drug or device study less than 30 days prior to enrollment in this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Pregnancy | Childbirth | Breast Feeding
Item
6. pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study.
boolean
C0032961 (UMLS CUI [1])
C1148523 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Illness | Use of Antibiotics | Use of Analgesics | Use of Antipyretics | Use of Cold medication
Item
7. acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.
boolean
C0221423 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1524063 (UMLS CUI [3,1])
C0002771 (UMLS CUI [3,2])
C1524063 (UMLS CUI [4,1])
C0003419 (UMLS CUI [4,2])
C1524063 (UMLS CUI [5,1])
C0742541 (UMLS CUI [5,2])