ID

16365

Description

ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00331097

Link

https://clinicaltrials.gov/show/NCT00331097

Keywords

Versions (1)
  1. 7/12/16 7/12/16 -
Uploaded on

July 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00331097

English

Eligibility Breast Cancer NCT00331097

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive unilateral breast cancer
Description

Invasive carcinoma of breast Unilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205092
age > 65 and < 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
intermediate-high risk of recurrence according to st. gallen criteria: er negative and pgr negative, or axillary lymph node metastasis, or tumor size > 2 cm, or tumor grade 2 or 3 (intermediate or high)
Description

Recurrence High risk Intermediate | Estrogen receptor negative | progesterone receptor negative | AXILLARY LYMPH NODE METASTASIS | Tumor size | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C2825055
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C3640764
UMLS CUI [2]
C0279756
UMLS CUI [3]
C0279766
UMLS CUI [4]
C0741344
UMLS CUI [5]
C0475440
UMLS CUI [6]
C3258246
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
performance status >1
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
distant metastasis
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1275402
concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
Description

Malignant Neoplasms | Basal cell carcinoma Treated Adequate | Spinocellular carcinoma Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C1168311
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C0205411
previous breast cancer treatment
Description

Breast Cancer Therapeutic Procedure

Data type

boolean

Alias
UMLS CUI [1]
C1511300
neutrophils < 2000/mm3 or platelets < 100000/mm3 or haemoglobin < 10 g/dl
Description

Absolute neutrophil count | Blood Platelets | Hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
creatinine > 1.25 the upper normal limit
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
got and-or gpt and/or bilirubin > 1.25 the upper normal limit
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
concomitant conditions that contraindicate the use of the drugs in the protocol
Description

Medical contraindication Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
incapacity or refusal to provide informed consent
Description

Informed Consent Unable | Informed Consent Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
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Similar models

Eligibility Breast Cancer NCT00331097

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Unilateral
Item
histologically confirmed invasive unilateral breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
Age
Item
age > 65 and < 80 years
boolean
C0001779 (UMLS CUI [1])
Recurrence High risk Intermediate | Estrogen receptor negative | progesterone receptor negative | AXILLARY LYMPH NODE METASTASIS | Tumor size | TNM clinical staging
Item
intermediate-high risk of recurrence according to st. gallen criteria: er negative and pgr negative, or axillary lymph node metastasis, or tumor size > 2 cm, or tumor grade 2 or 3 (intermediate or high)
boolean
C2825055 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C3640764 (UMLS CUI [1,3])
C0279756 (UMLS CUI [2])
C0279766 (UMLS CUI [3])
C0741344 (UMLS CUI [4])
C0475440 (UMLS CUI [5])
C3258246 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
performance status
Item
performance status >1
boolean
C1518965 (UMLS CUI [1])
Distant metastasis
Item
distant metastasis
boolean
C1275402 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma Treated Adequate | Spinocellular carcinoma Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate
Item
concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C1168311 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0205411 (UMLS CUI [4,3])
Breast Cancer Therapeutic Procedure
Item
previous breast cancer treatment
boolean
C1511300 (UMLS CUI [1])
Absolute neutrophil count | Blood Platelets | Hemoglobin
Item
neutrophils < 2000/mm3 or platelets < 100000/mm3 or haemoglobin < 10 g/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Creatinine measurement, serum
Item
creatinine > 1.25 the upper normal limit
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
got and-or gpt and/or bilirubin > 1.25 the upper normal limit
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Medical contraindication Investigational New Drugs
Item
concomitant conditions that contraindicate the use of the drugs in the protocol
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Refused
Item
incapacity or refusal to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
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