ID

38212

Beschrijving

2-weeks of Adjuvant Radiotherapy in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02460744

Link

https://clinicaltrials.gov/show/NCT02460744

Trefwoorden

  1. 27-09-19 27-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 september 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02460744

Eligibility Breast Cancer NCT02460744

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
invasive carcinoma of the breast
Beschrijving

invasive carcinoma breast

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
breast conservation surgery or mastectomy (reconstruction allowed but not with implant. tissue expanders with distant metal ports are allowed)
Beschrijving

Breast-Conserving Surgery | Mastectomy | Mammaplasty allowed | Breast implants Absent | Breast tissue expander allowed

Datatype

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2]
C0024881
UMLS CUI [3,1]
C0085076
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0179412
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0588162
UMLS CUI [5,2]
C0683607
axillary staging &/or dissection
Beschrijving

Axillary lymph nodes TNM clinical staging | Excision of axillary lymph nodes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0729594
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0193867
complete microscopic excision of primary tumour
Beschrijving

Primary tumor Complete excision Microscopic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0015250
UMLS CUI [1,3]
C0205288
pt1-3 pn0-2 m0 disease
Beschrijving

Disease TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
able to comply with follow up n.b. concurrent trastuzumab and hormone therapy is allowed
Beschrijving

Compliance behavior Follow-up | Trastuzumab allowed | Hormone Therapy allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0683607
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
past history of malignancy except (i) basal cell skin cancer and cin cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
Beschrijving

Malignant Neoplasm In the past | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Cancer Other | Exception Disease Free of Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C1707251
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
contralateral breast cancer, including dcis, irrespective of date of diagnosis
Beschrijving

Breast Carcinoma Contralateral | DCIS

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0441988
UMLS CUI [2]
C0007124
breast reconstruction using implants
Beschrijving

Mammaplasty Using Breast implants

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085076
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0179412
concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
Beschrijving

Cytotoxic Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0677881

Similar models

Eligibility Breast Cancer NCT02460744

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
invasive carcinoma breast
Item
invasive carcinoma of the breast
boolean
C0853879 (UMLS CUI [1])
Breast-Conserving Surgery | Mastectomy | Mammaplasty allowed | Breast implants Absent | Breast tissue expander allowed
Item
breast conservation surgery or mastectomy (reconstruction allowed but not with implant. tissue expanders with distant metal ports are allowed)
boolean
C0917927 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
C0085076 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0179412 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0588162 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
Axillary lymph nodes TNM clinical staging | Excision of axillary lymph nodes
Item
axillary staging &/or dissection
boolean
C0729594 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0193867 (UMLS CUI [2])
Primary tumor Complete excision Microscopic
Item
complete microscopic excision of primary tumour
boolean
C0677930 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
C0205288 (UMLS CUI [1,3])
Disease TNM Breast tumor staging
Item
pt1-3 pn0-2 m0 disease
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Follow-up | Trastuzumab allowed | Hormone Therapy allowed
Item
able to comply with follow up n.b. concurrent trastuzumab and hormone therapy is allowed
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm In the past | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Cancer Other | Exception Disease Free of Duration
Item
past history of malignancy except (i) basal cell skin cancer and cin cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
boolean
C0006826 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C1707251 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Breast Carcinoma Contralateral | DCIS
Item
contralateral breast cancer, including dcis, irrespective of date of diagnosis
boolean
C0678222 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
Mammaplasty Using Breast implants
Item
breast reconstruction using implants
boolean
C0085076 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0179412 (UMLS CUI [1,3])
Cytotoxic Chemotherapy
Item
concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
boolean
C0677881 (UMLS CUI [1])

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