ID

14899

Beschrijving

Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT01831076

Link

https://clinicaltrials.gov/show/NCT01831076

Trefwoorden

  1. 05-05-16 05-05-16 -
  2. 26-06-16 26-06-16 -
Geüploaded op

5 mei 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Breast Cancer NCT01831076

Eligibility Breast Cancer NCT01831076

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed breast cancer
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1]
C0019638
er positive (+)
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1]
C2919271
primary tumor 2-4 regional lymph nodes 0-2 (t2-4n0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated
Beschrijving

ID.3

Datatype

boolean

clinical stage ii/iii
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1]
C1300072
postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
newly diagnosed
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1]
C1518321
patients with prior non-breast malignancies are eligible if they have been disease free for >= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (lcis) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization
Beschrijving

ID.7

Datatype

boolean

serum creatinine =< 1.5 x institutional upper limit of normal (uln)
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
hemoglobin within normal limits for institution
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
absolute granulocyte count >= 1500
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1]
C0857490
platelet count >= 100,000
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1]
C0005821
serum glutamic oxaloacetic transaminase (sgot), aspartate aminotransferase (ast) or serum glutamate pyruvate transaminase (sgpt), alanine aminotransferase (alt) =< 2.5 x uln
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1]
C0201899|C1557189
total bilirubin < 2 x uln for institution
Beschrijving

ID.13

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
alkaline phosphatase < 2 x the uln
Beschrijving

ID.14

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
completely resected
Beschrijving

ID.15

Datatype

boolean

Alias
UMLS CUI [1]
C0015250
prior hormone or chemotherapy
Beschrijving

ID.16

Datatype

boolean

Alias
UMLS CUI [1]
C1514457|C0279025
unable to take oral medication
Beschrijving

ID.17

Datatype

boolean

Alias
UMLS CUI [1]
C0011168
patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy
Beschrijving

ID.18

Datatype

boolean

Alias
UMLS CUI [1]
C0442893

Similar models

Eligibility Breast Cancer NCT01831076

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
histologically or cytologically confirmed breast cancer
boolean
C0019638 (UMLS CUI [1])
ID.2
Item
er positive (+)
boolean
C2919271 (UMLS CUI [1])
ID.3
Item
primary tumor 2-4 regional lymph nodes 0-2 (t2-4n0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated
boolean
ID.4
Item
clinical stage ii/iii
boolean
C1300072 (UMLS CUI [1])
ID.5
Item
postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year
boolean
C0232970 (UMLS CUI [1])
ID.6
Item
newly diagnosed
boolean
C1518321 (UMLS CUI [1])
ID.7
Item
patients with prior non-breast malignancies are eligible if they have been disease free for >= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (lcis) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization
boolean
ID.8
Item
serum creatinine =< 1.5 x institutional upper limit of normal (uln)
boolean
C0201976 (UMLS CUI [1])
ID.9
Item
hemoglobin within normal limits for institution
boolean
C0019046 (UMLS CUI [1])
ID.10
Item
absolute granulocyte count >= 1500
boolean
C0857490 (UMLS CUI [1])
ID.11
Item
platelet count >= 100,000
boolean
C0005821 (UMLS CUI [1])
ID.12
Item
serum glutamic oxaloacetic transaminase (sgot), aspartate aminotransferase (ast) or serum glutamate pyruvate transaminase (sgpt), alanine aminotransferase (alt) =< 2.5 x uln
boolean
C0201899|C1557189 (UMLS CUI [1])
ID.13
Item
total bilirubin < 2 x uln for institution
boolean
C1278039 (UMLS CUI [1])
ID.14
Item
alkaline phosphatase < 2 x the uln
boolean
C0201850 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.15
Item
completely resected
boolean
C0015250 (UMLS CUI [1])
ID.16
Item
prior hormone or chemotherapy
boolean
C1514457|C0279025 (UMLS CUI [1])
ID.17
Item
unable to take oral medication
boolean
C0011168 (UMLS CUI [1])
ID.18
Item
patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy
boolean
C0442893 (UMLS CUI [1])

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