ID

37754

Description

Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00821613

Link

https://clinicaltrials.gov/show/NCT00821613

Keywords

Versions (1)
  1. 8/21/19 8/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00821613

English

Eligibility Breast Cancer NCT00821613

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
gender: female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age: 18 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with a breast abnormality (identified by mammography, ultrasound, mri and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
Description

Abnormality of the breast Mammography | Abnormality of the breast Ultrasonography | Abnormality of the breast MRI | Abnormality of the breast Clinical examination | Abnormality of the breast Requirement Biopsy of breast | Study Subject Requirement Screening examination

Data type

boolean

Alias
UMLS CUI [1,1]
C4025829
UMLS CUI [1,2]
C0024671
UMLS CUI [2,1]
C4025829
UMLS CUI [2,2]
C0041618
UMLS CUI [3,1]
C4025829
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C4025829
UMLS CUI [4,2]
C1456356
UMLS CUI [5,1]
C4025829
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0405352
UMLS CUI [6,1]
C0681850
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0281974
subject who have signed an informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have had a mammography, ultrasound, and/or mri examination performed on the day of the study, prior to being "imaged" by ri4.0.
Description

Mammography Currently | Ultrasonography Currently | MRI Currently

Data type

boolean

Alias
UMLS CUI [1,1]
C0024671
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C0041618
UMLS CUI [2,2]
C0521116
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C0521116
subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
Description

Operation on breast

Data type

boolean

Alias
UMLS CUI [1]
C3714726
subjects 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
subjects who have undergone a mastectomy.
Description

Mastectomy

Data type

boolean

Alias
UMLS CUI [1]
C0024881
subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
Description

Scar Large | Scar Causing Deformity of breast | Status post Lumpectomy of breast | Cause Other | Cause Accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0241158
UMLS CUI [1,2]
C0549177
UMLS CUI [2,1]
C0241158
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0567474
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0851238
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0205394
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0000924
subjects with prior breast reduction surgery or breast augmentation surgery.
Description

Reduction mammaplasty | Augmentation mammoplasty

Data type

boolean

Alias
UMLS CUI [1]
C0191922
UMLS CUI [2]
C0191925
subjects who have a fever on the day of their biopsy.
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
subjects who are pregnant.
Description

Pregnancy

Data type

boolean

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

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Breast Cancer NCT00821613

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
gender: female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age: 18 years and older
boolean
C0001779 (UMLS CUI [1])
Abnormality of the breast Mammography | Abnormality of the breast Ultrasonography | Abnormality of the breast MRI | Abnormality of the breast Clinical examination | Abnormality of the breast Requirement Biopsy of breast | Study Subject Requirement Screening examination
Item
subjects with a breast abnormality (identified by mammography, ultrasound, mri and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
boolean
C4025829 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C4025829 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
C4025829 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C4025829 (UMLS CUI [4,1])
C1456356 (UMLS CUI [4,2])
C4025829 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0405352 (UMLS CUI [5,3])
C0681850 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0281974 (UMLS CUI [6,3])
Informed Consent
Item
subject who have signed an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mammography Currently | Ultrasonography Currently | MRI Currently
Item
subjects who have had a mammography, ultrasound, and/or mri examination performed on the day of the study, prior to being "imaged" by ri4.0.
boolean
C0024671 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0041618 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C0024485 (UMLS CUI [3,1])
C0521116 (UMLS CUI [3,2])
Operation on breast
Item
subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
boolean
C3714726 (UMLS CUI [1])
Biopsy of breast
Item
subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
boolean
C0405352 (UMLS CUI [1])
Mastectomy
Item
subjects who have undergone a mastectomy.
boolean
C0024881 (UMLS CUI [1])
Scar Large | Scar Causing Deformity of breast | Status post Lumpectomy of breast | Cause Other | Cause Accident
Item
subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
boolean
C0241158 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0241158 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0567474 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0851238 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0000924 (UMLS CUI [5,2])
Reduction mammaplasty | Augmentation mammoplasty
Item
subjects with prior breast reduction surgery or breast augmentation surgery.
boolean
C0191922 (UMLS CUI [1])
C0191925 (UMLS CUI [2])
Fever
Item
subjects who have a fever on the day of their biopsy.
boolean
C0015967 (UMLS CUI [1])
Pregnancy
Item
subjects who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
subjects who are breast-feeding.
boolean
C0006147 (UMLS CUI [1])
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