ID

15155

Beschreibung

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

Stichworte

  1. 19.05.16 19.05.16 -
Hochgeladen am

19. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
female gender
Beschreibung

Gender

Datentyp

boolean

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

Oestrogen receptor positive breast cancer

Datentyp

boolean

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

Human epidermal growth factor 2 negative carcinoma of breast

Datentyp

boolean

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

Postmenopausal state

Datentyp

boolean

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

H/O: hormone replacement (HRT)

Datentyp

boolean

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

Low grade histologic differentiation | Intermediate grade histologic differentiation

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Hematologic function Adequate | Normal renal function | Liver function Adequate

Datentyp

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
Beschreibung

Able to swallow oral medication

Datentyp

boolean

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

Tissue specimen Adequate Diagnosis | Biological Markers | MKI67 gene

Datentyp

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
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-menopausal women
Beschreibung

Woman Premenopausal

Datentyp

boolean

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

Locally advanced breast cancer | Carcinoma breast stage IV

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Hypersensitivity Estradiol | Intolerance to substance Estradiol

Datentyp

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
Beschreibung

Ischemic Change Electrocardiography

Datentyp

boolean

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

Cholelithiasis Symptomatic

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Vaginal Hemorrhage Abnormal | Malignant neoplasm of endometrium

Datentyp

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)
Beschreibung

metabolic disturbance | Glucose measurement | Triglycerides measurement

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

Ähnliche Modelle

Eligibility Estrogen Receptor Positive Breast Cancer NCT02238808

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])

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