ID

15155

Descrição

A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT02238808

Link

https://clinicaltrials.gov/show/NCT02238808

Palavras-chave

  1. 19/05/2016 19/05/2016 -
Transferido a

19 de maio de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female gender
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
estrogen receptor positive (er+) breast cancer
Descrição

Oestrogen receptor positive breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2938924
her2 negative breast cancer
Descrição

Human epidermal growth factor 2 negative carcinoma of breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2316304
post-menopausal by greater than 5 years
Descrição

Postmenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
no previous hormonal replacement therapy
Descrição

H/O: hormone replacement (HRT)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0455631
low to intermediate histologic grade
Descrição

Low grade histologic differentiation | Intermediate grade histologic differentiation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1302385
UMLS CUI [2]
C1320484
ecog performance status of 0 of 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematological, renal and hepatic function is required
Descrição

Hematologic function Adequate | Normal renal function | Liver function Adequate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205411
UMLS CUI [2]
C0232805
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0205411
ability to take oral medication
Descrição

Able to swallow oral medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
patient must have adequate tissue for diagnosis, biomarkers and ki67 assays
Descrição

Tissue specimen Adequate Diagnosis | Biological Markers | MKI67 gene

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0205411
UMLS CUI [1,3]
C0011900
UMLS CUI [2]
C0005516
UMLS CUI [3]
C1334508
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-menopausal women
Descrição

Woman Premenopausal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0279752
locally advanced or metastatic breast cancer
Descrição

Locally advanced breast cancer | Carcinoma breast stage IV

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0278488
current, previous or planning for pre-operative treatment with chemotherapy, hormone therapy including corticosteroids, radiation therapy for malignancy or other condition
Descrição

Neoadjuvant Therapy | Chemotherapy Regimen | Hormone Therapy | Adrenal Cortex Hormones | Therapeutic radiology procedure | Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0600558
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0001617
UMLS CUI [5]
C1522449
UMLS CUI [6]
C0006826
known hypersensitivity or intolerance to estradiol
Descrição

Hypersensitivity Estradiol | Intolerance to substance Estradiol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014912
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0014912
ischemic changes on baseline electrocardiogram
Descrição

Ischemic Change Electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2826576
UMLS CUI [1,2]
C1623258
symptomatic but untreated cholelithiasis
Descrição

Cholelithiasis Symptomatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008350
UMLS CUI [1,2]
C0231220
history of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension or known inherited hypercoagulable disorder
Descrição

Deep Vein Thrombosis | Pulmonary Embolism | Cerebrovascular accident | Acute myocardial infarction | Congestive heart failure | Hypertensive disease | Thrombophilia, hereditary

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0155626
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0020538
UMLS CUI [7]
C2584620
undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer
Descrição

Vaginal Hemorrhage Abnormal | Malignant neoplasm of endometrium

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2979982
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C0007103
untreated metabolic disturbances (glucose > 11.0 mmol/l and triglycerides > 400 mg/dl)
Descrição

metabolic disturbance | Glucose measurement | Triglycerides measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0746556
UMLS CUI [2]
C0337438
UMLS CUI [3]
C0202236
current treatment with drugs known to be moderate or strong inhibitors of inducers of isoenzyme cyp3a4
Descrição

Therapeutic procedure Pharmaceutical Preparations | Inhibitors Cytochrome P-450 CYP3A4 Inducers

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0243077
UMLS CUI [2,2]
C3850041

Similar models

Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female gender
boolean
C0079399 (UMLS CUI [1])
Oestrogen receptor positive breast cancer
Item
estrogen receptor positive (er+) breast cancer
boolean
C2938924 (UMLS CUI [1])
Human epidermal growth factor 2 negative carcinoma of breast
Item
her2 negative breast cancer
boolean
C2316304 (UMLS CUI [1])
Postmenopausal state
Item
post-menopausal by greater than 5 years
boolean
C0232970 (UMLS CUI [1])
H/O: hormone replacement (HRT)
Item
no previous hormonal replacement therapy
boolean
C0455631 (UMLS CUI [1])
Low grade histologic differentiation | Intermediate grade histologic differentiation
Item
low to intermediate histologic grade
boolean
C1302385 (UMLS CUI [1])
C1320484 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status of 0 of 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function Adequate | Normal renal function | Liver function Adequate
Item
adequate hematological, renal and hepatic function is required
boolean
C0221130 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0232805 (UMLS CUI [2])
C0232741 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
Able to swallow oral medication
Item
ability to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Tissue specimen Adequate Diagnosis | Biological Markers | MKI67 gene
Item
patient must have adequate tissue for diagnosis, biomarkers and ki67 assays
boolean
C1292533 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0005516 (UMLS CUI [2])
C1334508 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Woman Premenopausal
Item
pre-menopausal women
boolean
C0043210 (UMLS CUI [1,1])
C0279752 (UMLS CUI [1,2])
Locally advanced breast cancer | Carcinoma breast stage IV
Item
locally advanced or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1])
C0278488 (UMLS CUI [2])
Neoadjuvant Therapy | Chemotherapy Regimen | Hormone Therapy | Adrenal Cortex Hormones | Therapeutic radiology procedure | Malignant Neoplasms
Item
current, previous or planning for pre-operative treatment with chemotherapy, hormone therapy including corticosteroids, radiation therapy for malignancy or other condition
boolean
C0600558 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0006826 (UMLS CUI [6])
Hypersensitivity Estradiol | Intolerance to substance Estradiol
Item
known hypersensitivity or intolerance to estradiol
boolean
C0020517 (UMLS CUI [1,1])
C0014912 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0014912 (UMLS CUI [2,2])
Ischemic Change Electrocardiography
Item
ischemic changes on baseline electrocardiogram
boolean
C2826576 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Cholelithiasis Symptomatic
Item
symptomatic but untreated cholelithiasis
boolean
C0008350 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Deep Vein Thrombosis | Pulmonary Embolism | Cerebrovascular accident | Acute myocardial infarction | Congestive heart failure | Hypertensive disease | Thrombophilia, hereditary
Item
history of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension or known inherited hypercoagulable disorder
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0155626 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0020538 (UMLS CUI [6])
C2584620 (UMLS CUI [7])
Vaginal Hemorrhage Abnormal | Malignant neoplasm of endometrium
Item
undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer
boolean
C2979982 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0007103 (UMLS CUI [2])
metabolic disturbance | Glucose measurement | Triglycerides measurement
Item
untreated metabolic disturbances (glucose > 11.0 mmol/l and triglycerides > 400 mg/dl)
boolean
C0746556 (UMLS CUI [1])
C0337438 (UMLS CUI [2])
C0202236 (UMLS CUI [3])
Therapeutic procedure Pharmaceutical Preparations | Inhibitors Cytochrome P-450 CYP3A4 Inducers
Item
current treatment with drugs known to be moderate or strong inhibitors of inducers of isoenzyme cyp3a4
boolean
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0243077 (UMLS CUI [2,1])
C3850041 (UMLS CUI [2,2])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial