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ID
27240
Beschrijving
Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01180335
Link
https://clinicaltrials.gov/show/NCT01180335
Trefwoorden
Versies (1)
- 04-11-17 04-11-17 -
Houder van rechten
See clinicaltrials.gov
Geüploaded op
4 november 2017
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01180335
Eligibility Breast Cancer NCT01180335
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT01180335
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Invasive carcinoma of breast | Ineligibility Breast-Conserving Surgery
Item
invasive breast cancer not eligible for conservative surgery
boolean
C0853879 (UMLS CUI [1])
C1512714 (UMLS CUI [2,1])
C0917927 (UMLS CUI [2,2])
C1512714 (UMLS CUI [2,1])
C0917927 (UMLS CUI [2,2])
HER2 negative
Item
her2 negative
boolean
C4087376 (UMLS CUI [1])
Neoplastic Cell Percentage | Other Coding
Item
amount of tumor cells >30% on hes slides
boolean
C0597032 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
C0439165 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
INR | RNA amount
Item
rin>6 and amount of rna>1 ug
boolean
C0525032 (UMLS CUI [1])
C0035668 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0035668 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Neoplasm Metastasis Absent
Item
no metastases
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Age
Item
subject, age > 18 years and <65 years old
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Performance status
Item
ps 0-1
boolean
C1518965 (UMLS CUI [1])
Prior Therapy Absent Breast Carcinoma
Item
no previous treatment for breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Left ventricular ejection fraction
Item
fevg >50%
boolean
C0428772 (UMLS CUI [1])
Carcinoma in Situ
Item
in situ carcinoma
boolean
C0007099 (UMLS CUI [1])
Multifocal breast carcinoma
Item
multifocal cancers
boolean
C2986662 (UMLS CUI [1])
HER2/Neu Positive
Item
her2+
boolean
C2348909 (UMLS CUI [1])
Neoplasm Metastasis
Item
presence of metastasis
boolean
C0027627 (UMLS CUI [1])
Genomic screening Unsuccessful | Neoplastic Cell Percentage | INR | RNA Amount Insufficient
Item
genomic testing not feasible because of tumor cells <30%, rin<6, insufficient amount of rna
boolean
C2349866 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0525032 (UMLS CUI [3])
C0035668 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0231180 (UMLS CUI [4,3])
C1272705 (UMLS CUI [1,2])
C0597032 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0525032 (UMLS CUI [3])
C0035668 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0231180 (UMLS CUI [4,3])
Organ dysfunction | Medical contraindication Chemotherapy
Item
organ dysfunction that contraindicates chemotherapy
boolean
C0349410 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1301624 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])