ID

35028

Description

Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02455154

Link

https://clinicaltrials.gov/show/NCT02455154

Keywords

Versions (1)
  1. 2/11/19 2/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02455154

English

Eligibility Breast Cancer NCT02455154

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive breast cancer;
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
post-surgery, primary lesion been removed;
Description

Status post Operative Surgical Procedures | Primary Lesion Removed

Data type

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C1402294
UMLS CUI [2,2]
C0849355
post-menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
Description

Postmenopausal state | Premenopausal state Impending Ovarian Function Tests

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0332190
UMLS CUI [2,3]
C0029930
histologically confirmed er and/or pr positive ;
Description

Estrogen receptor positive | Progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
receiving adjuvant ais therapy in the following one years;
Description

Aromatase Inhibitors Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0677850
leukocyte ≥ 3*10(9)/l; platelets ≥ 75*10(9)/l;
Description

White Blood Cell Count procedure | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
serum glutamate oxaloacetate(ast/sgot) or serum glutamic-pyruvic transaminase(alt/sgpt) <2.5 times of upper limit of normal range;
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine/blood urea nitrogen(bun) ≤ upper limit of normal (unl) range;
Description

Creatinine measurement, serum | Blood urea nitrogen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0005845
written informed consent according to the local ethics committee equirements;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic breast cancer;
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
received neo-adjuvant endocrine therapy;
Description

Hormone Therapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1298676
history of pelvic fracture or bone metabolic disease;
Description

Fracture of pelvis | Metabolic Bone Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0149531
UMLS CUI [2]
C0005944
received drugs interfering bone metabolism in the last 12 months;
Description

Pharmaceutical Preparations Interfering Bone metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596204
baseline bone mineral density: t < -2sd;
Description

Bone Mineral Density T score

Data type

boolean

Alias
UMLS CUI [1,1]
C0177804
UMLS CUI [1,2]
C3854607
with other primary malignant disease;
Description

Primary tumor Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0205394
with severe non-malignant co-morbidity that will influence long-term follow up;
Description

Comorbidity Severe Influence Long-term Follow-up | Exception Malignant disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C1517942
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0442867
known severe hypersensitivity to any drugs in this study;
Description

Severe allergy Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Breast Cancer NCT02455154

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
histologically confirmed invasive breast cancer;
boolean
C0853879 (UMLS CUI [1])
Status post Operative Surgical Procedures | Primary Lesion Removed
Item
post-surgery, primary lesion been removed;
boolean
C0231290 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1402294 (UMLS CUI [2,1])
C0849355 (UMLS CUI [2,2])
Postmenopausal state | Premenopausal state Impending Ovarian Function Tests
Item
post-menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
boolean
C0232970 (UMLS CUI [1])
C0232969 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C0029930 (UMLS CUI [2,3])
Estrogen receptor positive | Progesterone receptor positive
Item
histologically confirmed er and/or pr positive ;
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
Aromatase Inhibitors Adjuvant therapy
Item
receiving adjuvant ais therapy in the following one years;
boolean
C0593802 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
White Blood Cell Count procedure | Platelet Count measurement
Item
leukocyte ≥ 3*10(9)/l; platelets ≥ 75*10(9)/l;
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum glutamate oxaloacetate(ast/sgot) or serum glutamic-pyruvic transaminase(alt/sgpt) <2.5 times of upper limit of normal range;
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Blood urea nitrogen measurement
Item
serum creatinine/blood urea nitrogen(bun) ≤ upper limit of normal (unl) range;
boolean
C0201976 (UMLS CUI [1])
C0005845 (UMLS CUI [2])
Informed Consent
Item
written informed consent according to the local ethics committee equirements;
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer;
boolean
C0346993 (UMLS CUI [1])
Hormone Therapy Neoadjuvant
Item
received neo-adjuvant endocrine therapy;
boolean
C0279025 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
Fracture of pelvis | Metabolic Bone Disorder
Item
history of pelvic fracture or bone metabolic disease;
boolean
C0149531 (UMLS CUI [1])
C0005944 (UMLS CUI [2])
Pharmaceutical Preparations Interfering Bone metabolism
Item
received drugs interfering bone metabolism in the last 12 months;
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
Bone Mineral Density T score
Item
baseline bone mineral density: t < -2sd;
boolean
C0177804 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Primary tumor Other
Item
with other primary malignant disease;
boolean
C0677930 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comorbidity Severe Influence Long-term Follow-up | Exception Malignant disease
Item
with severe non-malignant co-morbidity that will influence long-term follow up;
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C1517942 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0442867 (UMLS CUI [2,2])
Severe allergy Investigational New Drugs
Item
known severe hypersensitivity to any drugs in this study;
boolean
C2945656 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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