ID

14880

Description

Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02271828

Link

https://clinicaltrials.gov/show/NCT02271828

Keywords

Versions (1)
  1. 5/3/16 5/3/16 -
Uploaded on

May 3, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02271828

English

Eligibility Breast Neoplasms NCT02271828

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
aged 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pathologically confirmed invasive breast carcinoma
Description

Invasive breast carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0853879
a clinical t1-2 tumor
Description

Tumor stage T1 | Tumor stage T2

Data type

boolean

Alias
UMLS CUI [1]
C0475372
UMLS CUI [2]
C0475373
will be treated with lumpectomy and whole breast radiotherapy
Description

Lumpectomy (breast cancer) | Whole breast Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0740370
UMLS CUI [2,1]
C0457102
UMLS CUI [2,2]
C1522449
clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
Description

Clinically node negative (t1n0m0) or t2n0m0) invasive breast cancer | Axillary lymph node level Absence of signs Neoplasm Metastasis | Physical Examination | Ultrasonics (sound) Preoperative Axilla | Cytopathology finding Negative | Histopathology finding Negative

Data type

boolean

Alias
UMLS CUI [1]
C3248613
UMLS CUI [2,1]
C0441924
UMLS CUI [2,2]
C0277791
UMLS CUI [2,3]
C0027627
UMLS CUI [3]
C0031809
UMLS CUI [4,1]
C1456803
UMLS CUI [4,2]
C0445204
UMLS CUI [4,3]
C0004454
UMLS CUI [5,1]
C0456521
UMLS CUI [5,2]
C0205160
UMLS CUI [6,1]
C0428093
UMLS CUI [6,2]
C0205160
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically node positive pre-operative
Description

Axillary lymph node group Positive Preoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C1446409
UMLS CUI [1,3]
C0445204
bilateral breast cancer
Description

bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
evidence of metastatic disease
Description

Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C2939420
history of invasive breast cancer
Description

Invasive breast carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0853879
previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
Description

Prior Therapy Axilla | Operative Surgical Procedures | Therapeutic radiology procedure | Hidradenitis Suppurativa | Skin lesion | Melanocytic nevus

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0004454
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0162836
UMLS CUI [5]
C0037284
UMLS CUI [6]
C0027962
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
Description

Malignant Neoplasms Previous | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Carcinoma in Situ Breast Ipsilateral | Carcinoma in Situ Breast Contralateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
UMLS CUI [4]
C0851140
UMLS CUI [5,1]
C0007099
UMLS CUI [5,2]
C0006141
UMLS CUI [5,3]
C0441989
UMLS CUI [6,1]
C0007099
UMLS CUI [6,2]
C0006141
UMLS CUI [6,3]
C0441988
unable or unwilling to give informed consent
Description

Unable Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
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Similar models

Eligibility Breast Neoplasms NCT02271828

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])
Age
Item
aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Invasive breast carcinoma
Item
pathologically confirmed invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
Tumor stage T1 | Tumor stage T2
Item
a clinical t1-2 tumor
boolean
C0475372 (UMLS CUI [1])
C0475373 (UMLS CUI [2])
Lumpectomy (breast cancer) | Whole breast Therapeutic radiology procedure
Item
will be treated with lumpectomy and whole breast radiotherapy
boolean
C0740370 (UMLS CUI [1])
C0457102 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
Clinically node negative (t1n0m0) or t2n0m0) invasive breast cancer | Axillary lymph node level Absence of signs Neoplasm Metastasis | Physical Examination | Ultrasonics (sound) Preoperative Axilla | Cytopathology finding Negative | Histopathology finding Negative
Item
clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
boolean
C3248613 (UMLS CUI [1])
C0441924 (UMLS CUI [2,1])
C0277791 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3])
C1456803 (UMLS CUI [4,1])
C0445204 (UMLS CUI [4,2])
C0004454 (UMLS CUI [4,3])
C0456521 (UMLS CUI [5,1])
C0205160 (UMLS CUI [5,2])
C0428093 (UMLS CUI [6,1])
C0205160 (UMLS CUI [6,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axillary lymph node group Positive Preoperative
Item
clinically node positive pre-operative
boolean
C0729594 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
bilateral breast cancer
Item
bilateral breast cancer
boolean
C0281267 (UMLS CUI [1])
Metastatic Neoplasm
Item
evidence of metastatic disease
boolean
C2939420 (UMLS CUI [1])
Invasive breast carcinoma
Item
history of invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Prior Therapy Axilla | Operative Surgical Procedures | Therapeutic radiology procedure | Hidradenitis Suppurativa | Skin lesion | Melanocytic nevus
Item
previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
boolean
C1514463 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0162836 (UMLS CUI [4])
C0037284 (UMLS CUI [5])
C0027962 (UMLS CUI [6])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms Previous | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Carcinoma in Situ Breast Ipsilateral | Carcinoma in Situ Breast Contralateral
Item
other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before randomization
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0007099 (UMLS CUI [5,1])
C0006141 (UMLS CUI [5,2])
C0441989 (UMLS CUI [5,3])
C0007099 (UMLS CUI [6,1])
C0006141 (UMLS CUI [6,2])
C0441988 (UMLS CUI [6,3])
Unable Informed Consent
Item
unable or unwilling to give informed consent
boolean
C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
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