ID

37751

Description

Study of Statin as Neo-Adjuvant Therapy in Postmenopausal Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00816244

Link

https://clinicaltrials.gov/show/NCT00816244

Keywords

Versions (1)
  1. 8/21/19 8/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00816244

English

Eligibility Breast Cancer NCT00816244

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with primary breast cancer who are candidates for radical surgery.
Description

Gender | Breast Carcinoma Appropriate Surgery Radical

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0543467
UMLS CUI [2,4]
C0439807
breast tumours clinically ≥ 15 mm, nx, m0.
Description

Breast Carcinoma Size TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0474926
breast tumours identified on mammography and verified on fine needle aspiration.
Description

Breast Carcinoma Mammography | Breast Carcinoma Fine needle aspiration

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0024671
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1510483
age > 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status of ecog ≤ 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
laboratory requirements at the day of diagnosis (t1-):prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
Description

Renal function Estimated Blood specimen | Creatinine measurement, serum | Liver function Estimated Blood specimen | Transaminase Assay

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0750572
UMLS CUI [1,3]
C0178913
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0750572
UMLS CUI [3,3]
C0178913
UMLS CUI [4]
C0919834
prior to patient registration, written informed consent must be given according to ich/gcp, and national/local regulations.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
negative pregnancy test for pre menopausal women before inclusion in the trial
Description

Premenopausal state Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
Description

Anticholesteremic Agents | Statins | Fibrates | ezetimibe

Data type

boolean

Alias
UMLS CUI [1]
C0003277
UMLS CUI [2]
C0360714
UMLS CUI [3]
C1449704
UMLS CUI [4]
C1142985
prior breast cancer treatment.
Description

Prior Therapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
current hrt.
Description

Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282402
known liver disease.
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
history of hemorrhagic stroke.
Description

Brain hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0553692
psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
Description

Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Follow-up | Condition Familial Interferes with Protocol Compliance | Condition Familial Interferes with Follow-up | Sociological Factors Interfere with Protocol Compliance | Sociological Factors Interfere with Follow-up | Geographic Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0241888
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0241888
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C3274571
UMLS CUI [5,1]
C3850138
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C3850138
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C3274571
UMLS CUI [7,1]
C0017444
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0017444
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C3274571
history of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.
Description

Allergic Reaction Compound Atorvastatin Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0286651
UMLS CUI [1,4]
C2348205
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Similar models

Eligibility Breast Cancer NCT00816244

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma Appropriate Surgery Radical
Item
women with primary breast cancer who are candidates for radical surgery.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0439807 (UMLS CUI [2,4])
Breast Carcinoma Size TNM Breast tumor staging
Item
breast tumours clinically ≥ 15 mm, nx, m0.
boolean
C0678222 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Breast Carcinoma Mammography | Breast Carcinoma Fine needle aspiration
Item
breast tumours identified on mammography and verified on fine needle aspiration.
boolean
C0678222 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C1510483 (UMLS CUI [2,2])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status of ecog ≤ 1.
boolean
C1520224 (UMLS CUI [1])
Renal function Estimated Blood specimen | Creatinine measurement, serum | Liver function Estimated Blood specimen | Transaminase Assay
Item
laboratory requirements at the day of diagnosis (t1-):prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required.
boolean
C0232804 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0201976 (UMLS CUI [2])
C0232741 (UMLS CUI [3,1])
C0750572 (UMLS CUI [3,2])
C0178913 (UMLS CUI [3,3])
C0919834 (UMLS CUI [4])
Informed Consent
Item
prior to patient registration, written informed consent must be given according to ich/gcp, and national/local regulations.
boolean
C0021430 (UMLS CUI [1])
Premenopausal state Pregnancy test negative
Item
negative pregnancy test for pre menopausal women before inclusion in the trial
boolean
C0232969 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Anticholesteremic Agents | Statins | Fibrates | ezetimibe
Item
ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe).
boolean
C0003277 (UMLS CUI [1])
C0360714 (UMLS CUI [2])
C1449704 (UMLS CUI [3])
C1142985 (UMLS CUI [4])
Prior Therapy Breast Carcinoma
Item
prior breast cancer treatment.
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Hormone replacement therapy
Item
current hrt.
boolean
C0282402 (UMLS CUI [1])
Liver disease
Item
known liver disease.
boolean
C0023895 (UMLS CUI [1])
Brain hemorrhage
Item
history of hemorrhagic stroke.
boolean
C0553692 (UMLS CUI [1])
Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Follow-up | Condition Familial Interferes with Protocol Compliance | Condition Familial Interferes with Follow-up | Sociological Factors Interfere with Protocol Compliance | Sociological Factors Interfere with Follow-up | Geographic Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Follow-up
Item
psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0241888 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C3274571 (UMLS CUI [4,4])
C3850138 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C3850138 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0017444 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C3274571 (UMLS CUI [8,3])
Allergic Reaction Compound Atorvastatin Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0286651 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
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