ID

27317

Beschrijving

Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00437359

Link

https://clinicaltrials.gov/show/NCT00437359

Trefwoorden

Versies (1)
  1. 08-11-17 08-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00437359

Engels

Eligibility Breast Neoplasms NCT00437359

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
written consent obtained for study participation.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
breast cancer diagnosed histologically with a breast removed or preserved.
Beschrijving

Breast Carcinoma | Mastectomy | Breast Preserved

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0024881
UMLS CUI [3,1]
C0006141
UMLS CUI [3,2]
C0033085
positive er or pr testing by immunohistochemistry (ihc), enzyme immunoassay (eia) and who meet the criteria of each institution.
Beschrijving

Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry | Estrogen receptor positive Enzyme Immunoassay | Progesterone receptor positive Enzyme Immunoassay

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279754
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C0279759
UMLS CUI [2,2]
C0021044
UMLS CUI [3,1]
C0279754
UMLS CUI [3,2]
C0086231
UMLS CUI [4,1]
C0279759
UMLS CUI [4,2]
C0086231
her2 evaluation.
Beschrijving

HER2/Neu Status Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C1261322
patient status (ps): 0 or 1.
Beschrijving

Performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
fully functional heart, liver, kidneys, and bone marrow.
Beschrijving

Cardiac function | Liver function | Renal function | Bone Marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0031843
more than one year since last menstruation or tested postmenopausal from estradiol (e2) and follicle-stimulating hormone (fsh) levels based on evaluation standard of each institution.
Beschrijving

Postmenopausal state Estradiol measurement | Postmenopausal state Follicle stimulating hormone measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0337434
UMLS CUI [2,1]
C0232970
UMLS CUI [2,2]
C0202022
expected to live for at least three months (or longer) after study commencement.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast feeding.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
bilateral or inflammatory breast cancer.
Beschrijving

Bilateral breast cancer | Inflammatory Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C0278601
multiple cancers.
Beschrijving

Multiple malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0346429
life-threatening metastases.
Beschrijving

Neoplasm Metastasis Life Threatening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C2826244
history of serious hypersensitivity.
Beschrijving

Hypersensitivity Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0205404
judged ineligible for the study by the study doctor.
Beschrijving

Ineligibility Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0008976
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Similar models

Eligibility Breast Neoplasms NCT00437359

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written consent obtained for study participation.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma | Mastectomy | Breast Preserved
Item
breast cancer diagnosed histologically with a breast removed or preserved.
boolean
C0678222 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
C0006141 (UMLS CUI [3,1])
C0033085 (UMLS CUI [3,2])
Estrogen receptor positive Immunohistochemistry | Progesterone receptor positive Immunohistochemistry | Estrogen receptor positive Enzyme Immunoassay | Progesterone receptor positive Enzyme Immunoassay
Item
positive er or pr testing by immunohistochemistry (ihc), enzyme immunoassay (eia) and who meet the criteria of each institution.
boolean
C0279754 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0279759 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C0279754 (UMLS CUI [3,1])
C0086231 (UMLS CUI [3,2])
C0279759 (UMLS CUI [4,1])
C0086231 (UMLS CUI [4,2])
HER2/Neu Status Evaluation
Item
her2 evaluation.
boolean
C1512413 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
Performance status
Item
patient status (ps): 0 or 1.
boolean
C1518965 (UMLS CUI [1])
Cardiac function | Liver function | Renal function | Bone Marrow function
Item
fully functional heart, liver, kidneys, and bone marrow.
boolean
C0232164 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
Postmenopausal state Estradiol measurement | Postmenopausal state Follicle stimulating hormone measurement
Item
more than one year since last menstruation or tested postmenopausal from estradiol (e2) and follicle-stimulating hormone (fsh) levels based on evaluation standard of each institution.
boolean
C0232970 (UMLS CUI [1,1])
C0337434 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2,1])
C0202022 (UMLS CUI [2,2])
Life Expectancy
Item
expected to live for at least three months (or longer) after study commencement.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Bilateral breast cancer | Inflammatory Breast Carcinoma
Item
bilateral or inflammatory breast cancer.
boolean
C0281267 (UMLS CUI [1])
C0278601 (UMLS CUI [2])
Multiple malignancy
Item
multiple cancers.
boolean
C0346429 (UMLS CUI [1])
Neoplasm Metastasis Life Threatening
Item
life-threatening metastases.
boolean
C0027627 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Hypersensitivity Serious
Item
history of serious hypersensitivity.
boolean
C0020517 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Ineligibility Clinical Trial
Item
judged ineligible for the study by the study doctor.
boolean
C1512714 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
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