ID

16262

Descripción

Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00198237

Link

https://clinicaltrials.gov/show/NCT00198237

Palabras clave

Versiones (1)
  1. 8/7/16 8/7/16 -
Subido en

8 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00198237

Inglés

Eligibility Breast Cancer NCT00198237

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the breast w/ stage ii-iii disease w/ a primary tumor >/=2cm or clinically palpable axillary lymph nodes.
Descripción

Breast adenocarcinoma | TNM clinical staging | Primary tumor size | Lymph nodes Axillary Palpable Clinical

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2]
C3258246
UMLS CUI [3]
C1302656
UMLS CUI [4,1]
C0024204
UMLS CUI [4,2]
C0004454
UMLS CUI [4,3]
C0522499
UMLS CUI [4,4]
C0205210
pre-treatment core or incisional bx w/ adequate tissue for histology &
Descripción

Core biopsy Pretreatment | Incisional biopsy | Tissue Adequate Histology Procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C3539076
UMLS CUI [2]
C0184922
UMLS CUI [3,1]
C0040300
UMLS CUI [3,2]
C0205411
UMLS CUI [3,3]
C0344441
genomic/proteomic analysis.
Descripción

Genome Analysis | Proteome Analysis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017428
UMLS CUI [1,2]
C0936012
UMLS CUI [2,1]
C0751973
UMLS CUI [2,2]
C0936012
primary tumor must be bi-dimensionally measurable by physical exam or dx breast imaging. measurements must be obtained w/in 3 wks prior to study entry.
Descripción

primary tumor Measurable 2-Dimensional | Physical Examination | Diagnostic Imaging Female breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1705052
UMLS CUI [2]
C0031809
UMLS CUI [3,1]
C0011923
UMLS CUI [3,2]
C0222603
adequate organ fxn:agc>1500; hb>/=9.0;plts>/=100k; crt</=2.0;cacl crt clr>/=50; total bili</=uln; lfts<2.0 uln
Descripción

organ function | Absolute neutrophil count | Hemoglobin | Blood Platelets | Creatinine measurement, serum | Creatinine clearance measurement | Bilirubin, total measurement | Liver Function Tests

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0005821
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0373595
UMLS CUI [7]
C0201913
UMLS CUI [8]
C0023901
ecog performance status 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
neg. pregnancy test
Descripción

Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pts may not have had definitive primary surgery.
Descripción

Operative Surgical Procedures Primary Definitive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0443196
metastatic breast cancer
Descripción

Carcinoma breast stage IV

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278488
any prior chemo or hormonal therapy for breast cancer
Descripción

Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0678222
prior history of malignancy w/in the previous 5 yrs.
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
no active unresolved infection
Descripción

Communicable Disease physiologic resolution

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514893
no major surgery w/in 2wks of start of study
Descripción

major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Breast Cancer NCT00198237

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma | TNM clinical staging | Primary tumor size | Lymph nodes Axillary Palpable Clinical
Item
histologically confirmed adenocarcinoma of the breast w/ stage ii-iii disease w/ a primary tumor >/=2cm or clinically palpable axillary lymph nodes.
boolean
C0858252 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
C1302656 (UMLS CUI [3])
C0024204 (UMLS CUI [4,1])
C0004454 (UMLS CUI [4,2])
C0522499 (UMLS CUI [4,3])
C0205210 (UMLS CUI [4,4])
Core biopsy Pretreatment | Incisional biopsy | Tissue Adequate Histology Procedure
Item
pre-treatment core or incisional bx w/ adequate tissue for histology &
boolean
C1318309 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
C0184922 (UMLS CUI [2])
C0040300 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
C0344441 (UMLS CUI [3,3])
Genome Analysis | Proteome Analysis
Item
genomic/proteomic analysis.
boolean
C0017428 (UMLS CUI [1,1])
C0936012 (UMLS CUI [1,2])
C0751973 (UMLS CUI [2,1])
C0936012 (UMLS CUI [2,2])
primary tumor Measurable 2-Dimensional | Physical Examination | Diagnostic Imaging Female breast
Item
primary tumor must be bi-dimensionally measurable by physical exam or dx breast imaging. measurements must be obtained w/in 3 wks prior to study entry.
boolean
C0677930 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1705052 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0011923 (UMLS CUI [3,1])
C0222603 (UMLS CUI [3,2])
organ function | Absolute neutrophil count | Hemoglobin | Blood Platelets | Creatinine measurement, serum | Creatinine clearance measurement | Bilirubin, total measurement | Liver Function Tests
Item
adequate organ fxn:agc>1500; hb>/=9.0;plts>/=100k; crt</=2.0;cacl crt clr>/=50; total bili</=uln; lfts<2.0 uln
boolean
C0678852 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
C0201913 (UMLS CUI [7])
C0023901 (UMLS CUI [8])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Pregnancy test negative
Item
neg. pregnancy test
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedures Primary Definitive
Item
pts may not have had definitive primary surgery.
boolean
C0543467 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0443196 (UMLS CUI [1,3])
Carcinoma breast stage IV
Item
metastatic breast cancer
boolean
C0278488 (UMLS CUI [1])
Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma
Item
any prior chemo or hormonal therapy for breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Malignant Neoplasms
Item
prior history of malignancy w/in the previous 5 yrs.
boolean
C0006826 (UMLS CUI [1])
Communicable Disease physiologic resolution
Item
no active unresolved infection
boolean
C0009450 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
major surgery
Item
no major surgery w/in 2wks of start of study
boolean
C0679637 (UMLS CUI [1])
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