ID

34912

Description

Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT02009150

Link

https://clinicaltrials.gov/show/NCT02009150

Keywords

Versions (1)
  1. 2/4/19 2/4/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 4, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02009150

English

Eligibility Breast Cancer NCT02009150

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
woman has read, understood and signed the inform consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age: 20 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
women who are asymptomatic for breast cancer
Description

Breast Carcinoma Asymptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0231221
proven carriers of deleterious brca1 or brca2 mutations or women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on gail or clause risk models
Description

Deleterious BRCA1 Gene Mutation | Deleterious BRCA2 Gene Mutation | Lifetime Risk Percentage Breast Carcinoma Gail model | Lifetime Risk Percentage Breast Carcinoma Claus Model

Data type

boolean

Alias
UMLS CUI [1]
C4289700
UMLS CUI [2]
C4287905
UMLS CUI [3,1]
C1517878
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0678222
UMLS CUI [3,4]
C1511297
UMLS CUI [4,1]
C1517878
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0678222
UMLS CUI [4,4]
C1707405
women scheduled to undergo routine mammography and/or us or mri screening
Description

Routine Mammography Scheduled | Ultrasonography Scheduled | MRI Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0205547
UMLS CUI [1,2]
C0024671
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0041618
UMLS CUI [2,2]
C0205539
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C0205539
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who have had a mammography and/or ultrasound examination performed on the day of the study prior to mira scan
Description

Mammography | Ultrasonography | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0024671
UMLS CUI [2]
C0041618
UMLS CUI [3]
C3846158
women who had a lumpectomy surgery up to 5 years preceding the study
Description

Segmental Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C0024885
women who had undergone mastectomy and/or reconstruction
Description

Mastectomy | Mammaplasty

Data type

boolean

Alias
UMLS CUI [1]
C0024881
UMLS CUI [2]
C0085076
women who have undergone any type of breast surgery throughout the 6 months preceding the study
Description

Operation on breast Type Any

Data type

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
women who have had a breast biopsy performed throughout the 6 weeks preceding the study.
Description

Biopsy of breast

Data type

boolean

Alias
UMLS CUI [1]
C0405352
women who have a fever on the day of the mira imaging
Description

Fever | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2]
C3846158
women who are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
women who are breast-feeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
women who had undergone breast reduction/augmentation
Description

Reduction mammaplasty | Augmentation mammoplasty

Data type

boolean

Alias
UMLS CUI [1]
C0191922
UMLS CUI [2]
C0191925
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Similar models

Eligibility Breast Cancer NCT02009150

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Informed Consent
Item
woman has read, understood and signed the inform consent form
boolean
C0021430 (UMLS CUI [1])
Age
Item
age: 20 years and older
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma Asymptomatic
Item
women who are asymptomatic for breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
Deleterious BRCA1 Gene Mutation | Deleterious BRCA2 Gene Mutation | Lifetime Risk Percentage Breast Carcinoma Gail model | Lifetime Risk Percentage Breast Carcinoma Claus Model
Item
proven carriers of deleterious brca1 or brca2 mutations or women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on gail or clause risk models
boolean
C4289700 (UMLS CUI [1])
C4287905 (UMLS CUI [2])
C1517878 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
C1511297 (UMLS CUI [3,4])
C1517878 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0678222 (UMLS CUI [4,3])
C1707405 (UMLS CUI [4,4])
Routine Mammography Scheduled | Ultrasonography Scheduled | MRI Scheduled
Item
women scheduled to undergo routine mammography and/or us or mri screening
boolean
C0205547 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0024485 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Mammography | Ultrasonography | Other Coding
Item
women who have had a mammography and/or ultrasound examination performed on the day of the study prior to mira scan
boolean
C0024671 (UMLS CUI [1])
C0041618 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Segmental Mastectomy
Item
women who had a lumpectomy surgery up to 5 years preceding the study
boolean
C0024885 (UMLS CUI [1])
Mastectomy | Mammaplasty
Item
women who had undergone mastectomy and/or reconstruction
boolean
C0024881 (UMLS CUI [1])
C0085076 (UMLS CUI [2])
Operation on breast Type Any
Item
women who have undergone any type of breast surgery throughout the 6 months preceding the study
boolean
C3714726 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Biopsy of breast
Item
women who have had a breast biopsy performed throughout the 6 weeks preceding the study.
boolean
C0405352 (UMLS CUI [1])
Fever | Other Coding
Item
women who have a fever on the day of the mira imaging
boolean
C0015967 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Pregnancy
Item
women who are pregnant
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
women who are breast-feeding
boolean
C0006147 (UMLS CUI [1])
Reduction mammaplasty | Augmentation mammoplasty
Item
women who had undergone breast reduction/augmentation
boolean
C0191922 (UMLS CUI [1])
C0191925 (UMLS CUI [2])
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