ID

27240

Descripción

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

Palabras clave

  1. 4/11/17 4/11/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de noviembre de 2017

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01180335

Eligibility Breast Cancer NCT01180335

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
invasive breast cancer not eligible for conservative surgery
Descripción

Invasive carcinoma of breast | Ineligibility Breast-Conserving Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0917927
her2 negative
Descripción

HER2 negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4087376
amount of tumor cells >30% on hes slides
Descripción

Neoplastic Cell Percentage | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0439165
UMLS CUI [2]
C3846158
rin>6 and amount of rna>1 ug
Descripción

INR | RNA amount

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2,1]
C0035668
UMLS CUI [2,2]
C1265611
no metastases
Descripción

Neoplasm Metastasis Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
subject, age > 18 years and <65 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
signed written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
ps 0-1
Descripción

Performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518965
no previous treatment for breast cancer
Descripción

Prior Therapy Absent Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
adequate organ function
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
fevg >50%
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
in situ carcinoma
Descripción

Carcinoma in Situ

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007099
multifocal cancers
Descripción

Multifocal breast carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2986662
her2+
Descripción

HER2/Neu Positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348909
presence of metastasis
Descripción

Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027627
genomic testing not feasible because of tumor cells <30%, rin<6, insufficient amount of rna
Descripción

Genomic screening Unsuccessful | Neoplastic Cell Percentage | INR | RNA Amount Insufficient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2349866
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C0525032
UMLS CUI [4,1]
C0035668
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0231180
organ dysfunction that contraindicates chemotherapy
Descripción

Organ dysfunction | Medical contraindication Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0349410
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0392920

Similar models

Eligibility Breast Cancer NCT01180335

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Neoplasm Metastasis Absent
Item
no metastases
boolean
C0027627 (UMLS CUI [1,1])
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])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Left ventricular ejection fraction
Item
fevg >50%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])

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