ID

13308

Description

Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes; ODM derived from: https://clinicaltrials.gov/show/NCT00668616

Link

https://clinicaltrials.gov/show/NCT00668616

Keywords

Versions (2)
  1. 2/1/16 2/1/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

February 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00668616

English

Eligibility Breast Cancer NCT00668616

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with histologically proven breast cancer (pt1/pt2/pt3, pn1, n0)
Description

Breast Cancer staging

Data type

boolean

Alias
UMLS CUI [1]
C0474926
ecog performance status 0-1
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
start of adjuvant therapy not later than 4 weeks after surgery
Description

Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0808070
hematology: platelets at least 100xgpt/l, neutrophiles at least 2xgpt/l
Description

Hematological status

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C2238207
normal liver function as defined by: bilirubine till 1.5 x normal value, sgot/sgpt till 1.25 x normal value
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
normal kidney function as defined by: creatine till 1.5 x normal value
Description

Kidney function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
negative pregnancy test for patients before menopause and effective contraception
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0700589
written informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior radiation, chemotherapy, hormontherapy and immunotherapy
Description

Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0851346
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
|C0021083
patients with more than 3 afflicted lymph nodes
Description

Staging: Lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C2216721
afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
Description

Staging: lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0441988
UMLS CUI [2]
C0229730
UMLS CUI [3]
C0229743
bilateral breast cancer or second carcinoma of the breast
Description

Further breast malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C0346993
inflammatory breast cancer and/or distant metastases
Description

inflammatory breast cancer, distant metastases

Data type

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2]
C1268959
existing clinically relevant peripheral neuropathie
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least lown ii
Description

Cardiac status

Data type

boolean

Alias
UMLS CUI [1]
C1096253
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0003811
patients with active infections and/or not controlled hypercalcemia
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C3714514
UMLS CUI [2]
C0020437
pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva
Description

gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
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Similar models

Eligibility Breast Cancer NCT00668616

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Cancer staging
Item
women with histologically proven breast cancer (pt1/pt2/pt3, pn1, n0)
boolean
C0474926 (UMLS CUI [1])
ecog performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Adjuvant therapy
Item
start of adjuvant therapy not later than 4 weeks after surgery
boolean
C0677850 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Hematological status
Item
hematology: platelets at least 100xgpt/l, neutrophiles at least 2xgpt/l
boolean
C0032181 (UMLS CUI [1])
C2238207 (UMLS CUI [2])
Liver function
Item
normal liver function as defined by: bilirubine till 1.5 x normal value, sgot/sgpt till 1.25 x normal value
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Kidney function
Item
normal kidney function as defined by: creatine till 1.5 x normal value
boolean
C0201976 (UMLS CUI [1])
Gynaecological status
Item
negative pregnancy test for patients before menopause and effective contraception
boolean
C0032976 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapy
Item
prior radiation, chemotherapy, hormontherapy and immunotherapy
boolean
C0851346 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
|C0021083 (UMLS CUI [3,2])
Staging: Lymph nodes
Item
patients with more than 3 afflicted lymph nodes
boolean
C2216721 (UMLS CUI [1])
Staging: lymph nodes
Item
afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
boolean
C0024204 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
C0229730 (UMLS CUI [2])
C0229743 (UMLS CUI [3])
Further breast malignancies
Item
bilateral breast cancer or second carcinoma of the breast
boolean
C0281267 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
inflammatory breast cancer, distant metastases
Item
inflammatory breast cancer and/or distant metastases
boolean
C0278601 (UMLS CUI [1])
C1268959 (UMLS CUI [2])
peripheral neuropathy
Item
existing clinically relevant peripheral neuropathie
boolean
C0031117 (UMLS CUI [1])
Cardiac status
Item
heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least lown ii
boolean
C1096253 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
Comorbidity
Item
patients with active infections and/or not controlled hypercalcemia
boolean
C3714514 (UMLS CUI [1])
C0020437 (UMLS CUI [2])
gynaecological status
Item
pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
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