Informatie:
Fout:
ID
12982
Beschrijving
Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00301548
Link
https://clinicaltrials.gov/show/NCT00301548
Trefwoorden
Versies (1)
- 09-01-16 09-01-16 -
Geüploaded op
9 januari 2016
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00301548
Eligibility Breast Neoplasms NCT00301548
- StudyEvent: Eligibility
Similar models
Eligibility Breast Neoplasms NCT00301548
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
histology, tumor size, er, pgr
Item
patients with breast cancer histologically proven > 2 cm, er and pgr <20% or any er and pgr absent (t2,t3 n0-2, m0)
boolean
C0019638 (UMLS CUI [1])
C0475440 (UMLS CUI [2])
C2919271 (UMLS CUI [3])
C2919590 (UMLS CUI [4])
C0475440 (UMLS CUI [2])
C2919271 (UMLS CUI [3])
C2919590 (UMLS CUI [4])
chemotherapy, hormone therapy
Item
no treatment with previous chemotherapy/hormonotherapy
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0279025 (UMLS CUI [2])
ecog
Item
performance status 0-2 (ecog scale, appendix 2)
boolean
C1520224 (UMLS CUI [1])
measurable disease
Item
measurable or evaluable lesions
boolean
C1513041 (UMLS CUI [1])
age
Item
age between 18-70 years
boolean
C0001779 (UMLS CUI [1])
comorbidity
Item
no significant intercurrent illness such as diabetes, cardiovascular, renal or neurologic impairments
boolean
C0009488 (UMLS CUI [1])
psychiatric illness
Item
absence of psychiatric illness
boolean
C0004936 (UMLS CUI [1])
wbc, platelet count
Item
wbc > 4,000/mm3; plts > 100,000/mm3
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0032181 (UMLS CUI [2])
ast, alt, ldh, gamm-gt, bilirubin
Item
ast, alt, ldh, gamma-gt < 2.5 x upper limit of normal and bilirubin < 3 mg/100 ml
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0202113 (UMLS CUI [3])
C0202035 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201836 (UMLS CUI [2])
C0202113 (UMLS CUI [3])
C0202035 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
informed consent
Item
informed consent obtained
boolean
C0021430 (UMLS CUI [1])
pregnancy test, contraception
Item
pregnancy test (in fertile women). an effective contraceptive method must be utilized by fertile women.
boolean
C0032976 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
diagnostic procedure
Item
baseline examinations (chest x ray, ct scan, ecg etc) performed within one month prior initiation to therapy
boolean
C0430022 (UMLS CUI [1])
infection, metabolic diseases
Item
uncontrolled infection and metabolite disease
boolean
C0009450 (UMLS CUI [1])
C0025517 (UMLS CUI [2])
C0025517 (UMLS CUI [2])
metastasis
Item
distant metastases
boolean
C0027627 (UMLS CUI [1])
neurological disease
Item
active peripheric and/or central neurological disease
boolean
C0027765 (UMLS CUI [1])
cardiac disease
Item
active cardiac disease defined as chf (nyha iii-iv) significant arrhytmias, bilateral bundle branch block or recent (less than 3 months) history of myocardial infarction
boolean
C0018799 (UMLS CUI [1])
malignancy
Item
history of second malignancy (exception in situ carcinoma of the uterine cervix and basal or squamous cell carcinoma of the skin)
boolean
C0006826 (UMLS CUI [1])