ID

22532

Descripción

Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00603408

Link

https://clinicaltrials.gov/show/NCT00603408

Palabras clave

  1. 7/6/17 7/6/17 -
Subido en

7 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00603408

Eligibility Breast Cancer NCT00603408

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be >= 18 years of age
Descripción

ID.1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
Descripción

ID.2

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1134719
tumor classified as clinically stage t2, t3 or t4 with any n (nx, n1, n2, or n3).
Descripción

ID.3

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0178759
tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, her2/neu
Descripción

ID.4

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0041366
adequate organ function defined as:
Descripción

ID.5

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
serum creatinine <= 1.5 x upper limit of institutional normal.
Descripción

ID.6

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600061
alt, ast, alk phos <= 1.5 x upper limit of institutional normal.
Descripción

ID.7

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001899
UMLS CUI [1,2]
C0004002
UMLS CUI [1,3]
C0002059
bilirubin <= 1.5 x upper limit of institutional normal.
Descripción

ID.8

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005437
normal left ventricular function (lvef > 50%) by muga or echo.
Descripción

ID.9

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0080310
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
no evidence of distant metastasis present by ct, bone scan, or physical exam. if the bone scan or ct scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as pet or mri.
Descripción

ID.10

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027627
no prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
Descripción

ID.11

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0455471
women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
Descripción

ID.12

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232973
UMLS CUI [1,2]
C0009862
karnofsky performance status of <= 70.
Descripción

ID.13

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
patients with known history neural deficiencies (e.g. peripheral neuropathy).
Descripción

ID.14

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027765
patients with a known hearing impairment (hearing loss or severe tinnitus).
Descripción

ID.15

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1384666
male patients
Descripción

ID.16

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086582

Similar models

Eligibility Breast Cancer NCT00603408

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patients must be >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
boolean
C0011900 (UMLS CUI [1,1])
C1134719 (UMLS CUI [1,2])
ID.3
Item
tumor classified as clinically stage t2, t3 or t4 with any n (nx, n1, n2, or n3).
boolean
C0178759 (UMLS CUI [1])
ID.4
Item
tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, her2/neu
boolean
C0041366 (UMLS CUI [1])
ID.5
Item
adequate organ function defined as:
boolean
C0678852 (UMLS CUI [1])
ID.6
Item
serum creatinine <= 1.5 x upper limit of institutional normal.
boolean
C0600061 (UMLS CUI [1])
ID.7
Item
alt, ast, alk phos <= 1.5 x upper limit of institutional normal.
boolean
C0001899 (UMLS CUI [1,1])
C0004002 (UMLS CUI [1,2])
C0002059 (UMLS CUI [1,3])
ID.8
Item
bilirubin <= 1.5 x upper limit of institutional normal.
boolean
C0005437 (UMLS CUI [1])
ID.9
Item
normal left ventricular function (lvef > 50%) by muga or echo.
boolean
C0080310 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.10
Item
no evidence of distant metastasis present by ct, bone scan, or physical exam. if the bone scan or ct scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as pet or mri.
boolean
C0027627 (UMLS CUI [1])
ID.11
Item
no prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
boolean
C0455471 (UMLS CUI [1])
ID.12
Item
women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
boolean
C0232973 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])
ID.13
Item
karnofsky performance status of <= 70.
boolean
C0206065 (UMLS CUI [1])
ID.14
Item
patients with known history neural deficiencies (e.g. peripheral neuropathy).
boolean
C0027765 (UMLS CUI [1])
ID.15
Item
patients with a known hearing impairment (hearing loss or severe tinnitus).
boolean
C1384666 (UMLS CUI [1])
ID.16
Item
male patients
boolean
C0086582 (UMLS CUI [1])

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