Eligibility Breast Cancer NCT01634984

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. pathological confirmation of breast cancer
Beskrivning

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
3. tumor stage(tnm):t2-4bn0-3m0
Beskrivning

TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0474926
4. er(+) and/or pr(+).
Beskrivning

Estrogen receptor positive | Progesterone receptor positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
5. premenopausal woman.
Beskrivning

Premenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232969
6. age≥40 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
7. measurable disease as per recist criteria
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
8. karnofsky≥70
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
9. laboratory criteria:
Beskrivning

Laboratory criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
plt≥100*109/l
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
wbc≥4000/mm3
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
hgb≥10g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
alt and ast<2*uln
Beskrivning

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. presence of metastatic disease.
Beskrivning

Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
2. inflammatory breast cancer.
Beskrivning

Inflammatory Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0278601
3. bilateral breast cancer.
Beskrivning

Bilateral breast cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0281267
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
Beskrivning

Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0678222
5. other malignant tumor (concurrent or previous).
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
6. pregnant woman.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
7. hypersensitive to any drug in cef regimen or any ingredient of zoladex.
Beskrivning

Hypersensitivity Pharmaceutical Preparation CEF regimen | Hypersensitivity Ingredient Zoladex

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0248241
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1550600
UMLS CUI [2,3]
C0149473
8. any severe systemic disease contraindicating chemotherapy.
Beskrivning

Systemic disease Severe | Medical contraindication Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0392920

Similar models

Eligibility Breast Cancer NCT01634984

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of informed consent
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma
Item
2. pathological confirmation of breast cancer
boolean
C0678222 (UMLS CUI [1])
TNM Breast tumor staging
Item
3. tumor stage(tnm):t2-4bn0-3m0
boolean
C0474926 (UMLS CUI [1])
Estrogen receptor positive | Progesterone receptor positive
Item
4. er(+) and/or pr(+).
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
Premenopausal state
Item
5. premenopausal woman.
boolean
C0232969 (UMLS CUI [1])
Age
Item
6. age≥40 years
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
7. measurable disease as per recist criteria
boolean
C1513041 (UMLS CUI [1])
Karnofsky Performance Status
Item
8. karnofsky≥70
boolean
C0206065 (UMLS CUI [1])
Laboratory criteria
Item
9. laboratory criteria:
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Platelet Count measurement
Item
plt≥100*109/l
boolean
C0032181 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc≥4000/mm3
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement
Item
hgb≥10g/dl
boolean
C0518015 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt and ast<2*uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
1. presence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Inflammatory Breast Carcinoma
Item
2. inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
Bilateral breast cancer
Item
3. bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1])
Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma
Item
4. previous chemotherapy or hormonal therapy for current breast neoplasm.
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Cancer Other
Item
5. other malignant tumor (concurrent or previous).
boolean
C1707251 (UMLS CUI [1])
Pregnancy
Item
6. pregnant woman.
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity Pharmaceutical Preparation CEF regimen | Hypersensitivity Ingredient Zoladex
Item
7. hypersensitive to any drug in cef regimen or any ingredient of zoladex.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0248241 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C0149473 (UMLS CUI [2,3])
Systemic disease Severe | Medical contraindication Chemotherapy
Item
8. any severe systemic disease contraindicating chemotherapy.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])