ID

40821

Descripción

Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01589367

Link

https://clinicaltrials.gov/show/NCT01589367

Palabras clave

Versiones (1)
  1. 19/5/20 19/5/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

19 de mayo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hormone Receptor Positive Malignant Neoplasm of Breast NCT01589367

Inglés

Eligibility Hormone Receptor Positive Malignant Neoplasm of Breast NCT01589367

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
estrogen receptor positive breast cancer
Descripción

Oestrogen receptor positive breast cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2938924
clinically measurable tumor size(stage ii/iii)
Descripción

Tumor size Measurable | TNM Breast tumor staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1513040
UMLS CUI [2]
C0474926
no evidence of distant metastasis
Descripción

Distant metastasis absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
postmenopause women 'age≥60yr' or 'previous bilateral oophorectomy' or 'fsh>30 with no bleeding history within 1yr'
Descripción

Postmenopausal state | Age | Bilateral oophorectomy | Follicle stimulating hormone measurement | Hemorrhage Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0278321
UMLS CUI [4]
C0202022
UMLS CUI [5,1]
C0019080
UMLS CUI [5,2]
C0332197
ecog 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate hepatorenal, bone marrow function 'serum cr<1.4mg/dl' and 'bilirubin< upper limit of normal x 1.5 and 'ast/alt < upper limit of normal x 1.8 and 'alp < upper limit of normal x 1.8 and 'hemoglobin >10 g/dl' and 'anc >1,500/mm3' and 'platelet >100,000/mm3'
Descripción

Liver function | Renal function | Bone Marrow function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
UMLS CUI [4]
C0201976
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0201850
UMLS CUI [9]
C0518015
UMLS CUI [10]
C0948762
UMLS CUI [11]
C0032181
spontaneous signed into the written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
who does not meet the above inclusion criteria
Descripción

Inclusion criteria failed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0231175
history of other carcinoma
Descripción

Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
uncontrolled infection
Descripción

Communicable Disease Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
history of psychiatric, epileptic disease
Descripción

Mental disorders | Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0014544
male breast cancer
Descripción

Carcinoma of Male Breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0238033
diabetes 'hba1c≥6.5' or 'fbs≥126mg/dl'
Descripción

Diabetes Mellitus | Hemoglobin A1c measurement | Fasting Blood Sugar Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0474680
UMLS CUI [3]
C2825162
hypersensitivity or intolerance to metformin
Descripción

Metformin allergy | Intolerance to Metformin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571648
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025598
risk of metformin associated lactic acidosis 'congestive heart disease of nyha class llll/iv' or 'history of other acidosis' or 'alcohol intake more than either 3 bottles beer or 1 bottle soju'
Descripción

Risk Lactic Acidosis Associated with Metformin | Congestive heart failure New York Heart Association Classification | Acidosis | Alcohol intake above recommended sensible limits

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0001125
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C0025598
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0001122
UMLS CUI [4]
C0560219
during medication of metformin, sulfonylureas, thiazolidinediones, insulin
Descripción

Metformin | Sulfonylureas | Thiazolidinediones | Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
UMLS CUI [3]
C1257987
UMLS CUI [4]
C0021641
diffuse microcalcification in mammogram
Descripción

Mammographic microcalcification of breast Diffuse

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2830589
UMLS CUI [1,2]
C0205219
multiple or bilateral or inflammatory breast cancer
Descripción

Breast Carcinoma multiple | Bilateral breast cancer | Inflammatory Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0439064
UMLS CUI [2]
C0281267
UMLS CUI [3]
C0278601
chemotherapy or endocrine therapy within 2yr due to history of breast cancer
Descripción

Chemotherapy Due to Breast Carcinoma | Hormone Therapy Due to Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0678222
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Similar models

Eligibility Hormone Receptor Positive Malignant Neoplasm of Breast NCT01589367

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Oestrogen receptor positive breast cancer
Item
estrogen receptor positive breast cancer
boolean
C2938924 (UMLS CUI [1])
Tumor size Measurable | TNM Breast tumor staging
Item
clinically measurable tumor size(stage ii/iii)
boolean
C0475440 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0474926 (UMLS CUI [2])
Distant metastasis absent
Item
no evidence of distant metastasis
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Postmenopausal state | Age | Bilateral oophorectomy | Follicle stimulating hormone measurement | Hemorrhage Absent
Item
postmenopause women 'age≥60yr' or 'previous bilateral oophorectomy' or 'fsh>30 with no bleeding history within 1yr'
boolean
C0232970 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0278321 (UMLS CUI [3])
C0202022 (UMLS CUI [4])
C0019080 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
ECOG performance status
Item
ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function | Renal function | Bone Marrow function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
adequate hepatorenal, bone marrow function 'serum cr<1.4mg/dl' and 'bilirubin< upper limit of normal x 1.5 and 'ast/alt < upper limit of normal x 1.8 and 'alp < upper limit of normal x 1.8 and 'hemoglobin >10 g/dl' and 'anc >1,500/mm3' and 'platelet >100,000/mm3'
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0201976 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0201850 (UMLS CUI [8])
C0518015 (UMLS CUI [9])
C0948762 (UMLS CUI [10])
C0032181 (UMLS CUI [11])
Informed Consent
Item
spontaneous signed into the written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Inclusion criteria failed
Item
who does not meet the above inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Cancer Other
Item
history of other carcinoma
boolean
C1707251 (UMLS CUI [1])
Communicable Disease Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Mental disorders | Epilepsy
Item
history of psychiatric, epileptic disease
boolean
C0004936 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Carcinoma of Male Breast
Item
male breast cancer
boolean
C0238033 (UMLS CUI [1])
Diabetes Mellitus | Hemoglobin A1c measurement | Fasting Blood Sugar Measurement
Item
diabetes 'hba1c≥6.5' or 'fbs≥126mg/dl'
boolean
C0011849 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C2825162 (UMLS CUI [3])
Metformin allergy | Intolerance to Metformin
Item
hypersensitivity or intolerance to metformin
boolean
C0571648 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Risk Lactic Acidosis Associated with Metformin | Congestive heart failure New York Heart Association Classification | Acidosis | Alcohol intake above recommended sensible limits
Item
risk of metformin associated lactic acidosis 'congestive heart disease of nyha class llll/iv' or 'history of other acidosis' or 'alcohol intake more than either 3 bottles beer or 1 bottle soju'
boolean
C0035647 (UMLS CUI [1,1])
C0001125 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0025598 (UMLS CUI [1,4])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0001122 (UMLS CUI [3])
C0560219 (UMLS CUI [4])
Metformin | Sulfonylureas | Thiazolidinediones | Insulin
Item
during medication of metformin, sulfonylureas, thiazolidinediones, insulin
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
Mammographic microcalcification of breast Diffuse
Item
diffuse microcalcification in mammogram
boolean
C2830589 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
Breast Carcinoma multiple | Bilateral breast cancer | Inflammatory Breast Carcinoma
Item
multiple or bilateral or inflammatory breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0281267 (UMLS CUI [2])
C0278601 (UMLS CUI [3])
Chemotherapy Due to Breast Carcinoma | Hormone Therapy Due to Breast Carcinoma
Item
chemotherapy or endocrine therapy within 2yr due to history of breast cancer
boolean
C0392920 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
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