Information:
Fel:
ID
26088
Beskrivning
Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00617942
Länk
https://clinicaltrials.gov/show/NCT00617942
Nyckelord
Versioner (1)
- 2017-10-09 2017-10-09 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
9 oktober 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00617942
Eligibility Breast Cancer NCT00617942
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00617942
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Breast adenocarcinoma
Item
histologically documented adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1])
Absolute neutrophil count
Item
anc > 1000 cells
boolean
C0948762 (UMLS CUI [1])
Gender | Age | Zubrod Performance Status
Item
female; age > 18; zubrod ps 0-1
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3714786 (UMLS CUI [3])
C0001779 (UMLS CUI [2])
C3714786 (UMLS CUI [3])
Platelet Count measurement
Item
platelets > 100,000
boolean
C0032181 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage iia-iiib disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,2])
Serum total bilirubin measurement
Item
total bilirubin < or = uln
boolean
C1278039 (UMLS CUI [1])
Exclusion Criteria | Neoplasm Metastasis | Pregnancy | Breast Feeding
Item
no evidence of metastatic disease not pregnant or lactating
boolean
C0680251 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0027627 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Exclusion Criteria | Systemic therapy Breast Carcinoma
Item
no prior systemic therapy for this breast cancer
boolean
C0680251 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1515119 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
serum creatinine < 1.5 mg/dl or creat cl > 30 ml/min
boolean
C0201976 (UMLS CUI [1])
serum alanine aminotransferase measurement
Item
serum alt < 2.5 x uln
boolean
C1883008 (UMLS CUI [1])
Estrogen Receptor Status Required | Progesterone Receptor Status Required | HER2/Neu Status Required
Item
er, pr and her2 status required
boolean
C1516974 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1514471 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1512413 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1514873 (UMLS CUI [1,2])
C1514471 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1512413 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Left ventricular ejection fraction MUGA | Left ventricular ejection fraction Echocardiography
Item
lvef (muga/echo)wnl
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Neuropathy CTCAE Grades
Item
no baseline > 2 neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,2])
Hemoglobin measurement
Item
hemoglobin > 9.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
HER2/Neu Positive | Immunohistochemistry Positive | HER2/CEP17 Ratio FISH
Item
her2+, defined by ihc 3+ or fish ratio > 2.0
boolean
C2348909 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1977461 (UMLS CUI [3])
C0021044 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1977461 (UMLS CUI [3])