ID

16262

Description

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

Keywords

Versions (1)
  1. 7/8/16 7/8/16 -
Uploaded on

July 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00198237

English

Eligibility Breast Cancer NCT00198237

1 forms  
Inclusion Criteria
Description

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.
Description

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

Data type

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 &
Description

Core biopsy Pretreatment | Incisional biopsy | Tissue Adequate Histology Procedure

Data type

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.
Description

Genome Analysis | Proteome Analysis

Data type

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.
Description

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

Data type

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
Description

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

Data type

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
Description

ECOG performance status

Data type

boolean

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

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

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

Operative Surgical Procedures Primary Definitive

Data type

boolean

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

Carcinoma breast stage IV

Data type

boolean

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

Prior Chemotherapy Breast Carcinoma | Prior Hormone Therapy Breast Carcinoma

Data type

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.
Description

Malignant Neoplasms

Data type

boolean

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

Communicable Disease physiologic resolution

Data type

boolean

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

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Breast Cancer NCT00198237

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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