Informações:
Falhas:
ID
16284
Descrição
Study in Elderly Patients With Early Breast Cancer (ICE); ODM derived from: https://clinicaltrials.gov/show/NCT00196859
Link
https://clinicaltrials.gov/show/NCT00196859
Palavras-chave
Versões (1)
- 09/07/2016 09/07/2016 -
Transferido a
9 de julho de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00196859
Eligibility Breast Cancer NCT00196859
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00196859
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
written informed consent
Item
1. written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
boolean
C0021430 (UMLS CUI [1])
primary carcinoma of the breast
Item
2. histologically confirmed unilateral or bilateral primary carcinoma of the breast.
boolean
C1335475 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,2])
Age
Item
3. age at diagnosis ≥ 65 years
boolean
C0001779 (UMLS CUI [1])
Surgery outcome
Item
4. adequately surgical treatment with complete resection (ro) of the tumor and > or = 10 axillary nodes. sole sentinel node biopsy is allowed if the sentinel node shows no tumor involvement.
boolean
C0184788 (UMLS CUI [1,1])
C3714726 (UMLS CUI [1,2])
C3714726 (UMLS CUI [1,2])
Node positive or negative disease
Item
5. node positive disease irrespective of additional risk factors or node negative disease with at least one other risk factor (histologic tumor size > or = 2 cm, grade ii or iii, er and pr negative)
boolean
C3160887 (UMLS CUI [1])
C3160889 (UMLS CUI [2])
C3160889 (UMLS CUI [2])
distant metastasis
Item
6. no evidence for distant metastasis after complete diagnostic work up
boolean
C1302548 (UMLS CUI [1])
performance status ecog
Item
7. performance status ecog < or = 2
boolean
C1520224 (UMLS CUI [1])
Charlson scale
Item
8. charlson scale of < or = 2
boolean
C1516737 (UMLS CUI [1])
estimated life expectancy
Item
9. estimated life expectancy of at least 5 years (irrespective of breast cancer diagnosis)
boolean
C0023671 (UMLS CUI [1])
ID.10
Item
10. the patient must be accessible for treatment and follow-up.
boolean
C0814423 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,2])
drug hypersensitivity or dihydropyrimidine dehydrogenase deficiency
Item
1. known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
boolean
C0020517 (UMLS CUI [1])
C1959620 (UMLS CUI [2])
C1959620 (UMLS CUI [2])
inadequate organ function
Item
2. inadequate organ function including: leucocytes < 3,5 g/l, platelets < 100 g/l , bilirubin 1.25 times above normal limits, creatinine clearance calculated by the cockroft-gold formula of above 50 ml/min, uncompensated cardiac function, severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
boolean
C0679384 (UMLS CUI [1])
another primary malignancy
Item
3. another primary malignancy with an event-free survival of < 5 years, except curatively treated basalioma of the skin
boolean
C0009488 (UMLS CUI [1,1])
C0751623 (UMLS CUI [1,2])
C0751623 (UMLS CUI [1,2])
time since axillary dissection
Item
4. time since axillary dissection > 3 months
boolean
C1948053 (UMLS CUI [1,1])
C0193867 (UMLS CUI [1,2])
C0193867 (UMLS CUI [1,2])
locally advanced, non-operable breast cancer
Item
5. locally advanced, non-operable breast cancer
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,2])
previous invasive breast carcinoma
Item
6. previous invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
previous treatment with cytotoxic agents
Item
7. previous treatment with cytotoxic agents for any reason
boolean
C0304497 (UMLS CUI [1])
hormonal replacement therapy
Item
8. concurrent treatment with hormonal replacement therapy (treatment should be stopped before entering the trial).
boolean
C0282402 (UMLS CUI [1])
previous treatment with bisphosphonates
Item
9. previous treatment with bisphosphonates for osteoporosis is allowed, however this treatment has to be substituted by the trial medication
boolean
C3541401 (UMLS CUI [1])
Previous chemotherapy
Item
10. concurrent specific systemic anti-tumor treatment or treatment with experimental compounds within the last 6 months
boolean
C3665472 (UMLS CUI [1])
ID.21
Item
11. concurrent treatment with other tumor specific experimental drugs. participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
boolean
C0304229 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C2348568 (UMLS CUI [2])
Virustatic agents or aminoglycosides
Item
12. concurrent treatment with virostatic agents like brivudine or analoga sorivudine, concurrent treatment with aminoglycosides
boolean
C0003451 (UMLS CUI [1])
C0002556 (UMLS CUI [2])
C0002556 (UMLS CUI [2])
Gender
Item
13. male patients
boolean
C0079399 (UMLS CUI [1])