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ID
16004
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
Versies (2)
- 05-05-16 05-05-16 -
- 26-06-16 26-06-16 -
Geüploaded op
26 juni 2016
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01831076
Eligibility Breast Cancer NCT01831076
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT01831076
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
diagnosis of breast cancer
Item
histologically or cytologically confirmed breast cancer
boolean
C0019638 (UMLS CUI [1])
hormone receptor status
Item
er positive (+)
boolean
C2919271 (UMLS CUI [1])
primary tumor plus regional lymph nodes
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
tumor stage
Item
clinical stage ii/iii
boolean
C1300072 (UMLS CUI [1])
postmenopausal
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])
newly diagnosed
Item
newly diagnosed
boolean
C1518321 (UMLS CUI [1])
prior non-breast malignancies
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
serum creatinine
Item
serum creatinine =< 1.5 x institutional upper limit of normal (uln)
boolean
C0201976 (UMLS CUI [1])
hemoglobin
Item
hemoglobin within normal limits for institution
boolean
C0019046 (UMLS CUI [1])
granulocyte count
Item
absolute granulocyte count >= 1500
boolean
C0857490 (UMLS CUI [1])
platelet count
Item
platelet count >= 100,000
boolean
C0005821 (UMLS CUI [1])
GOT, AST, GPT, ALT
Item
serum glutamic oxaloacetic transaminase (sgot), aspartate aminotransferase (ast) or serum glutamate pyruvate transaminase (sgpt), alanine aminotransferase (alt) =< 2.5 x uln
boolean
C0201899 (UMLS CUI [1])
C1557189 (UMLS CUI [2])
C1557189 (UMLS CUI [2])
total bilirubin
Item
total bilirubin < 2 x uln for institution
boolean
C1278039 (UMLS CUI [1])
alkaline phosphatase
Item
alkaline phosphatase < 2 x the uln
boolean
C0201850 (UMLS CUI [1])
complete excision
Item
completely resected
boolean
C0015250 (UMLS CUI [1])
prior hormone or chemotherapy
Item
prior hormone or chemotherapy
boolean
C1514457|C0279025 (UMLS CUI [1])
Deglutition Disorders
Item
unable to take oral medication
boolean
C0011168 (UMLS CUI [1])
nonmalignant systemic disease
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])