ID

34910

Description

LOUIS-3D Breast Study; ODM derived from: https://clinicaltrials.gov/show/NCT01755130

Link

https://clinicaltrials.gov/show/NCT01755130

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 NCT01755130

English

Eligibility Breast Cancer NCT01755130

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. mass palpable or nonpalpable
Description

Palpable mass | Mass Non-Palpable

Data type

boolean

Alias
UMLS CUI [1]
C1403543
UMLS CUI [2,1]
C0577559
UMLS CUI [2,2]
C4086626
2. tissue density - all tissue types
Description

Tissue density | Tissue type All

Data type

boolean

Alias
UMLS CUI [1,1]
C0040300
UMLS CUI [1,2]
C0178587
UMLS CUI [2,1]
C2713035
UMLS CUI [2,2]
C0444868
3. menses - any stage of cycle
Description

Menses | Menstrual cycle Stage Any

Data type

boolean

Alias
UMLS CUI [1]
C0025344
UMLS CUI [2,1]
C0025329
UMLS CUI [2,2]
C1306673
UMLS CUI [2,3]
C1552551
4. age between 20-85 inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. breast size within specified size (e.g. a, b, c or d cup as appropriate per a fitting device)
Description

Breast size Within Size Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0425782
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C0205369
6. suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion(s)).
Description

Mass in breast Suspicious Mammography | Mass in breast Suspicious Ultrasonography | Indication Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0024103
UMLS CUI [1,2]
C0750493
UMLS CUI [1,3]
C0024671
UMLS CUI [2,1]
C0024103
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C0041618
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0005558
7. tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
Description

Cancer location Mammography | Cancer location Ultrasonography | Exception Chest wall Proximity

Data type

boolean

Alias
UMLS CUI [1,1]
C0872338
UMLS CUI [1,2]
C0024671
UMLS CUI [2,1]
C0872338
UMLS CUI [2,2]
C0041618
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205076
UMLS CUI [3,3]
C1514583
8. any tumor type (patients with inflammatory breast cancer may be included).
Description

Tumor type Any | Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C4263544
UMLS CUI [1,2]
C1552551
UMLS CUI [2]
C0278601
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient is unable or unwilling to give informed consent for any reason
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
2. disability (psychiatric, neurological or physical, which precludes examination)
Description

Mental handicap Excludes Medical Examination | Neurological disability Excludes Medical Examination | Physical disability Excludes Medical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0582103
UMLS CUI [2,1]
C0848771
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0582103
UMLS CUI [3,1]
C0520817
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0582103
3. patient has tattoos on the region of interest.
Description

Tattoos Region Interest

Data type

boolean

Alias
UMLS CUI [1,1]
C1366940
UMLS CUI [1,2]
C0205147
UMLS CUI [1,3]
C0543488
4. patient has body piercing jewelry through the nipple that cannot be removed.
Description

Body Piercing Jewelry Nipple

Data type

boolean

Alias
UMLS CUI [1,1]
C0848128
UMLS CUI [1,2]
C0336902
UMLS CUI [1,3]
C0028109
5. patient has had a core or excisional biopsy in the ipsilateral breast within the last 2 weeks (patients with previous fine needle aspirations but no ultrasound evidence of hematoma or post bx change may be included).
Description

Core needle biopsy Breast Ipsilateral | Excision biopsy Breast Ipsilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0184921
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C0441989
6. patient has inflammatory skin disease (i.e., psoriasis, eczema) affecting the breast.
Description

Inflammatory dermatosis Affecting Breast | Psoriasis | Eczema

Data type

boolean

Alias
UMLS CUI [1,1]
C3875321
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0006141
UMLS CUI [2]
C0033860
UMLS CUI [3]
C0013595
7. currently taking hormonal replacement therapy
Description

Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282402
8. non-ambulatory or unable to comply with exam
Description

Lacking Able to walk | Compliance behavior Unable Medical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1299582
UMLS CUI [2,3]
C0582103
9. weight in excess of exam table limits of 300 lb
Description

Body Weight Excessive

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0442802
10. pregnant (pregnancy test is not required, only as confirmed by patient).
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
11. breastfeeding
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
12. no prior breast treatment for target lesion
Description

Therapeutic procedure Breast Target Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C2986546
13. previous surgery of the breast in the last 3 months
Description

Operation on breast

Data type

boolean

Alias
UMLS CUI [1]
C3714726
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Similar models

Eligibility Breast Cancer NCT01755130

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Palpable mass | Mass Non-Palpable
Item
1. mass palpable or nonpalpable
boolean
C1403543 (UMLS CUI [1])
C0577559 (UMLS CUI [2,1])
C4086626 (UMLS CUI [2,2])
Tissue density | Tissue type All
Item
2. tissue density - all tissue types
boolean
C0040300 (UMLS CUI [1,1])
C0178587 (UMLS CUI [1,2])
C2713035 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Menses | Menstrual cycle Stage Any
Item
3. menses - any stage of cycle
boolean
C0025344 (UMLS CUI [1])
C0025329 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Age
Item
4. age between 20-85 inclusive
boolean
C0001779 (UMLS CUI [1])
Breast size Within Size Specified
Item
5. breast size within specified size (e.g. a, b, c or d cup as appropriate per a fitting device)
boolean
C0425782 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Mass in breast Suspicious Mammography | Mass in breast Suspicious Ultrasonography | Indication Biopsy
Item
6. suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion(s)).
boolean
C0024103 (UMLS CUI [1,1])
C0750493 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0024103 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0041618 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Cancer location Mammography | Cancer location Ultrasonography | Exception Chest wall Proximity
Item
7. tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
boolean
C0872338 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0872338 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0205076 (UMLS CUI [3,2])
C1514583 (UMLS CUI [3,3])
Tumor type Any | Inflammatory Breast Carcinoma
Item
8. any tumor type (patients with inflammatory breast cancer may be included).
boolean
C4263544 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C0278601 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Informed Consent Unwilling
Item
1. patient is unable or unwilling to give informed consent for any reason
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Mental handicap Excludes Medical Examination | Neurological disability Excludes Medical Examination | Physical disability Excludes Medical Examination
Item
2. disability (psychiatric, neurological or physical, which precludes examination)
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0582103 (UMLS CUI [1,3])
C0848771 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0582103 (UMLS CUI [2,3])
C0520817 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0582103 (UMLS CUI [3,3])
Tattoos Region Interest
Item
3. patient has tattoos on the region of interest.
boolean
C1366940 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C0543488 (UMLS CUI [1,3])
Body Piercing Jewelry Nipple
Item
4. patient has body piercing jewelry through the nipple that cannot be removed.
boolean
C0848128 (UMLS CUI [1,1])
C0336902 (UMLS CUI [1,2])
C0028109 (UMLS CUI [1,3])
Core needle biopsy Breast Ipsilateral | Excision biopsy Breast Ipsilateral
Item
5. patient has had a core or excisional biopsy in the ipsilateral breast within the last 2 weeks (patients with previous fine needle aspirations but no ultrasound evidence of hematoma or post bx change may be included).
boolean
C1318309 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0184921 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
Inflammatory dermatosis Affecting Breast | Psoriasis | Eczema
Item
6. patient has inflammatory skin disease (i.e., psoriasis, eczema) affecting the breast.
boolean
C3875321 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0033860 (UMLS CUI [2])
C0013595 (UMLS CUI [3])
Hormone replacement therapy
Item
7. currently taking hormonal replacement therapy
boolean
C0282402 (UMLS CUI [1])
Lacking Able to walk | Compliance behavior Unable Medical Examination
Item
8. non-ambulatory or unable to comply with exam
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0582103 (UMLS CUI [2,3])
Body Weight Excessive
Item
9. weight in excess of exam table limits of 300 lb
boolean
C0005910 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
Pregnancy
Item
10. pregnant (pregnancy test is not required, only as confirmed by patient).
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
11. breastfeeding
boolean
C0006147 (UMLS CUI [1])
Therapeutic procedure Breast Target Lesion
Item
12. no prior breast treatment for target lesion
boolean
C0087111 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C2986546 (UMLS CUI [1,3])
Operation on breast
Item
13. previous surgery of the breast in the last 3 months
boolean
C3714726 (UMLS CUI [1])
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