ID

38352

Description

ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid; ODM derived from: https://clinicaltrials.gov/show/NCT02218385

Link

https://clinicaltrials.gov/show/NCT02218385

Keywords

Versions (1)
  1. 10/11/19 10/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02218385

English

Eligibility Breast Neoplasms NCT02218385

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. healthy, female, age 20-75 years, from whom bi-lateral specimens can be obtained.
Description

Healthy | Gender | Age | Availability of Specimen Bilateral

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0470187
UMLS CUI [4,2]
C0370003
UMLS CUI [4,3]
C0238767
2. any woman for whom naf cytology testing is considered to be beneficial by her physician.
Description

Gender | Nipple Aspirate Fluid Cytology test Favorable

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C2717761
UMLS CUI [2,2]
C1305671
UMLS CUI [2,3]
C3640814
3. non-lactating and non-pregnant (as documented by date of last menstrual period or post-menopausal).
Description

Breast Feeding Absent | Pregnancy Absent | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0232970
4. good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.
Description

General health good | Determined by Medical History | Determined by Breast Disease History | Determined by History of cancer | Determined by Examination of breast

Data type

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0521095
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0521095
UMLS CUI [3,2]
C0006145
UMLS CUI [3,3]
C0262926
UMLS CUI [4,1]
C0521095
UMLS CUI [4,2]
C0455471
UMLS CUI [5,1]
C0521095
UMLS CUI [5,2]
C0199850
5. willing to give informed consent and follow study procedures as directed.
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the principal investigator.
Description

Medical condition Study Subject Participation Status Poor | Mental condition Study Subject Participation Status Poor

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2700379
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2700379
2. pregnancy or suspicion of pregnancy.
Description

Pregnancy | Suspicion Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C0032961
3. open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.
Description

Open wound Cutaneous | Atopic Dermatitis Area Areola of nipple

Data type

boolean

Alias
UMLS CUI [1,1]
C0332798
UMLS CUI [1,2]
C0221912
UMLS CUI [2,1]
C0011615
UMLS CUI [2,2]
C0205146
UMLS CUI [2,3]
C0149537
4. no or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.
Description

Nipple Lacking | Inversion of nipple | Prior surgery Area Areola of nipple

Data type

boolean

Alias
UMLS CUI [1,1]
C0028109
UMLS CUI [1,2]
C0332268
UMLS CUI [2]
C0269269
UMLS CUI [3,1]
C0455610
UMLS CUI [3,2]
C0205146
UMLS CUI [3,3]
C0149537
5. participation in an investigational drug or device study less than 30 days prior to enrollment in this study.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
6. pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study.
Description

Pregnancy | Childbirth | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C1148523
UMLS CUI [3]
C0006147
7. acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.
Description

Illness | Use of Antibiotics | Use of Analgesics | Use of Antipyretics | Use of Cold medication

Data type

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0003232
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0002771
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C0003419
UMLS CUI [5,1]
C1524063
UMLS CUI [5,2]
C0742541
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Similar models

Eligibility Breast Neoplasms NCT02218385

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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