ID

34986

Description

Breast Cancer Margin Delineation Using Polarization Subtraction Imaging Technology; ODM derived from: https://clinicaltrials.gov/show/NCT02207179

Link

https://clinicaltrials.gov/show/NCT02207179

Keywords

Versions (1)
  1. 2/6/19 2/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02207179

English

Eligibility Breast Cancer NCT02207179

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women referred for breast conservation surgery following a diagnosis of invasive or in situ carcinoma of the breast by histopathology or women referred for lumpectomy due to a benign (fibroadenoma or papilloma) or high risk breast lesion(atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical papilloma).
Description

Gender | Referral for Breast-Conserving Surgery | Invasive carcinoma of breast | Carcinoma in situ of female breast | Segmental Mastectomy Due to Lesion of breast Benign | Fibroadenoma of breast | Papilloma of breast | Segmental Mastectomy Due to High risk Lesion of breast | Atypical ductal hyperplasia | Atypical lobular hyperplasia | Lobular carcinoma in situ of breast | Atypical Breast Papilloma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C2585524
UMLS CUI [2,2]
C0917927
UMLS CUI [3]
C0853879
UMLS CUI [4]
C0686288
UMLS CUI [5,1]
C0024885
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0567489
UMLS CUI [5,4]
C0205183
UMLS CUI [6]
C0178421
UMLS CUI [7]
C4060446
UMLS CUI [8,1]
C0024885
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C4319571
UMLS CUI [8,4]
C0567489
UMLS CUI [9]
C0442834
UMLS CUI [10]
C0442835
UMLS CUI [11]
C0279563
UMLS CUI [12]
C1332346
2. 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. able to read or understand and give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients undergoing neo-adjuvant systemic therapy.
Description

Neoadjuvant Therapy Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0205373
2. previous breast cancer and /or radiation in the operated breast.
Description

Breast Carcinoma Previous | Operation on breast Associated with Radiotherapy to breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C3714726
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0948310
3. implants in the operated breast.
Description

Operation on breast Associated with Breast implant

Data type

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0178391
4. pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. history of photosensitizing disease (porphyria, lupus etc.) or of allergy to methylene blue dye.
Description

Photosensitivity Disorders | Porphyria | Lupus Erythematosus | Hypersensitivity Methylene blue

Data type

boolean

Alias
UMLS CUI [1]
C0031762
UMLS CUI [2]
C0032708
UMLS CUI [3]
C0409974
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0025746
6. recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy.
Description

Photosensitizing Agents | Fluoroquinolones | Retinoids | Phototherapy

Data type

boolean

Alias
UMLS CUI [1]
C0162713
UMLS CUI [2]
C0949665
UMLS CUI [3]
C0035339
UMLS CUI [4]
C0031765
7. participation in any other intraoperative margin assessment protocol that would affect data acquisition.
Description

Study Subject Participation Status | Surgical margins Intraoperative Assessment | Study Protocol Affecting Data Acquisition

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0229985
UMLS CUI [2,2]
C0456904
UMLS CUI [2,3]
C1516048
UMLS CUI [3,1]
C2348563
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1511726
UMLS CUI [3,4]
C1706701
8. subareolar location (cancer is directly and completely under the nipple/areolar complex) of breast abnormality.
Description

Abnormality of the breast Subareolar region

Data type

boolean

Alias
UMLS CUI [1,1]
C4025829
UMLS CUI [1,2]
C0447661
9. patients for whom english is not their native language
Description

Lacking Native language English

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2135511
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Similar models

Eligibility Breast Cancer NCT02207179

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Referral for Breast-Conserving Surgery | Invasive carcinoma of breast | Carcinoma in situ of female breast | Segmental Mastectomy Due to Lesion of breast Benign | Fibroadenoma of breast | Papilloma of breast | Segmental Mastectomy Due to High risk Lesion of breast | Atypical ductal hyperplasia | Atypical lobular hyperplasia | Lobular carcinoma in situ of breast | Atypical Breast Papilloma
Item
1. women referred for breast conservation surgery following a diagnosis of invasive or in situ carcinoma of the breast by histopathology or women referred for lumpectomy due to a benign (fibroadenoma or papilloma) or high risk breast lesion(atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in-situ, atypical papilloma).
boolean
C0079399 (UMLS CUI [1])
C2585524 (UMLS CUI [2,1])
C0917927 (UMLS CUI [2,2])
C0853879 (UMLS CUI [3])
C0686288 (UMLS CUI [4])
C0024885 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0567489 (UMLS CUI [5,3])
C0205183 (UMLS CUI [5,4])
C0178421 (UMLS CUI [6])
C4060446 (UMLS CUI [7])
C0024885 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C4319571 (UMLS CUI [8,3])
C0567489 (UMLS CUI [8,4])
C0442834 (UMLS CUI [9])
C0442835 (UMLS CUI [10])
C0279563 (UMLS CUI [11])
C1332346 (UMLS CUI [12])
Age
Item
2. 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
3. able to read or understand and give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoadjuvant Therapy Systemic
Item
1. patients undergoing neo-adjuvant systemic therapy.
boolean
C0600558 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Breast Carcinoma Previous | Operation on breast Associated with Radiotherapy to breast
Item
2. previous breast cancer and /or radiation in the operated breast.
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C3714726 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0948310 (UMLS CUI [2,3])
Operation on breast Associated with Breast implant
Item
3. implants in the operated breast.
boolean
C3714726 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0178391 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
4. pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Photosensitivity Disorders | Porphyria | Lupus Erythematosus | Hypersensitivity Methylene blue
Item
5. history of photosensitizing disease (porphyria, lupus etc.) or of allergy to methylene blue dye.
boolean
C0031762 (UMLS CUI [1])
C0032708 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0025746 (UMLS CUI [4,2])
Photosensitizing Agents | Fluoroquinolones | Retinoids | Phototherapy
Item
6. recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy.
boolean
C0162713 (UMLS CUI [1])
C0949665 (UMLS CUI [2])
C0035339 (UMLS CUI [3])
C0031765 (UMLS CUI [4])
Study Subject Participation Status | Surgical margins Intraoperative Assessment | Study Protocol Affecting Data Acquisition
Item
7. participation in any other intraoperative margin assessment protocol that would affect data acquisition.
boolean
C2348568 (UMLS CUI [1])
C0229985 (UMLS CUI [2,1])
C0456904 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C2348563 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1511726 (UMLS CUI [3,3])
C1706701 (UMLS CUI [3,4])
Abnormality of the breast Subareolar region
Item
8. subareolar location (cancer is directly and completely under the nipple/areolar complex) of breast abnormality.
boolean
C4025829 (UMLS CUI [1,1])
C0447661 (UMLS CUI [1,2])
Lacking Native language English
Item
9. patients for whom english is not their native language
boolean
C0332268 (UMLS CUI [1,1])
C2135511 (UMLS CUI [1,2])
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