Informações:
Falhas:
ID
19632
Descrição
Trastuzumab or Observation After Combination Chemotherapy and Trastuzumab in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00533936
Link
https://clinicaltrials.gov/show/NCT00533936
Palavras-chave
Versões (1)
- 17/01/2017 17/01/2017 -
Transferido a
17 de janeiro de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00533936
Eligibility Breast Cancer NCT00533936
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00533936
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Invasive carcinoma of breast Needle biopsy
Item
histologically confirmed invasive breast cancer by needle biopsy
boolean
C0853879 (UMLS CUI [1,1])
C0005560 (UMLS CUI [1,2])
C0005560 (UMLS CUI [1,2])
Diagnosis Timepoint
Item
diagnosed within the past 4 weeks
boolean
C0011900 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
Disease TNM clinical staging
Item
clinical stage iib, iiia, iiib, or iiic disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,2])
Lymphadenopathy Palpable
Item
palpable adenopathies present
boolean
C0497156 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C0522499 (UMLS CUI [1,2])
HER2-positive carcinoma of breast Evidence of
Item
her2/neu-positive disease, as evidenced by either of the following:
boolean
C1960398 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,2])
ERBB2 Protein Overexpression Immunohistochemistry
Item
her2/neu overexpression (3+) by immunohistochemistry (ihc)
boolean
C1515560 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,2])
HER2 gene amplification Fluorescent in Situ Hybridization
Item
her2/neu amplification by fluorescence in situ hybridization (fish)
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])
Neoplasm Metastasis Plain chest X-ray | Ultrasonography of liver | Radioisotope scan of bone
Item
no metastatic disease by chest radiography, hepatic ultrasound, and bone scan (metastatic bone series if no nuclear medicine is available)
boolean
C0027627 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0412534 (UMLS CUI [2])
C0203668 (UMLS CUI [3])
C0039985 (UMLS CUI [1,2])
C0412534 (UMLS CUI [2])
C0203668 (UMLS CUI [3])
Hormone Receptor Status
Item
hormone receptor status:
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
Estrogen Receptor Status Known | Progesterone Receptor Status Known
Item
estrogen receptor and/or progesterone receptor status known
boolean
C0034804 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C0034833 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C0034833 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Premenopausal state | Postmenopausal state
Item
premenopausal or postmenopausal
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0232970 (UMLS CUI [2])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Liver function | Renal function | Hematologic function
Item
normal hepatic, renal, and hematological function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
C0232804 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
Left ventricular ejection fraction Nuclear medicine procedure | Echocardiography
Item
lvef ≥ 55% by nuclear medicine study or echocardiogram
boolean
C0428772 (UMLS CUI [1,1])
C0203634 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
C0203634 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
Malignant Neoplasms | Carcinoma in situ of uterine cervix
Item
no prior history of cancer, except carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0851140 (UMLS CUI [2])
Paclitaxel allergy | Hypersensitivity trastuzumab | Hypersensitivity Herceptin
Item
no allergic reaction or hypersensitivity to paclitaxel and/or trastuzumab (herceptin®)
boolean
C0570707 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
C0020517 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
cancer treatment
Item
no prior cancer therapy
boolean
C0920425 (UMLS CUI [1])