ID

37908

Descripción

A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01210768

Link

https://clinicaltrials.gov/show/NCT01210768

Palabras clave

Versiones (1)
  1. 29/8/19 29/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

29 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01210768

Inglés

Eligibility Breast Cancer NCT01210768

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed invasive, but non-inflammatory, breast adenocarcinoma with stage i or ii (if n0, t must be >1cm) disease
Descripción

Breast adenocarcinoma Invasive Noninflammatory | Disease TNM Breast tumor staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0442743
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0474926
her2-negative on fluorescence in situ hybridization (fish) study
Descripción

HER2 Negative FISH

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C0162789
performance status of ecog 0, 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
female, age between 20 and 70 years
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
life expectancy of at least one year
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
ability to understand and willingness to sign a written informed consent document
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
her2 3+ over-expression on immunohistochemistry (ihc), or her2 amplification on fluorescence in situ hybridization (fish) study
Descripción

HER2 Protein Overexpression Immunohistochemistry | HER2 gene amplification FISH

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0162789
previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years
Descripción

Malignancy Systemic | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Disease Free Time Interval

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
UMLS CUI [4,4]
C0872291
patients who have received prior chemotherapy
Descripción

Prior Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
inadequate hematological function defined as absolute neutrophil count (anc)less than 1,500/mm3, and platelets less than 100,000/mm3
Descripción

Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
inadequate hepatic function defined as: serum bilirubin greater than 1.5 times the upper limit of normal range (uln) alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 2.5 times the uln
Descripción

Liver function Inadequate | Serum bilirubin increased | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0859062
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
inadequate renal function defined as serum creatinine greater than 1.5 times the uln
Descripción

Renal function Inadequate | Serum creatinine raised

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0700225
left ventricular ejection fraction (lvef) < 50% confirmed by multiple-gated acquisition (muga) scan or echocardiogram
Descripción

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
concomitant illness that might be aggregated by chemotherapy or interfere study assessment. for examples, active, non- controlled infection (such as hepatitis b and hepatitis c, hiv, infectious tuberculosis) or other active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia, unstable diabetes mellitus, and active peptic ulcer
Descripción

Comorbidity Aggregation Due to Chemotherapy | Comorbidity Interferes with Study Assessment | Communicable Disease Uncontrolled | Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis | Disease Uncontrolled | Congestive heart failure | Myocardial Ischemia | Uncontrolled hypertension | Cardiac Arrhythmia | Unstable diabetes mellitus | Peptic Ulcer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332621
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0392920
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2603343
UMLS CUI [2,4]
C1516048
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
UMLS CUI [6]
C0019693
UMLS CUI [7]
C0041296
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C0205318
UMLS CUI [9]
C0018802
UMLS CUI [10]
C0151744
UMLS CUI [11]
C1868885
UMLS CUI [12]
C0003811
UMLS CUI [13]
C0342302
UMLS CUI [14]
C0030920
patients who are presence of liver cirrhosis or are hbv/hcv carrier
Descripción

Liver Cirrhosis | Hepatitis B carrier | Hepatitis C carrier

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0262505
UMLS CUI [3]
C0400920
participation in another clinical trial with any investigational drug within 30 days prior to entry
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
pregnant or breast feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
Descripción

Childbearing Potential | Exception Use of Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0700589
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Similar models

Eligibility Breast Cancer NCT01210768

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma Invasive Noninflammatory | Disease TNM Breast tumor staging
Item
histologically confirmed invasive, but non-inflammatory, breast adenocarcinoma with stage i or ii (if n0, t must be >1cm) disease
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0442743 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
HER2 Negative FISH
Item
her2-negative on fluorescence in situ hybridization (fish) study
boolean
C2348908 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
ECOG performance status
Item
performance status of ecog 0, 1
boolean
C1520224 (UMLS CUI [1])
Gender | Age
Item
female, age between 20 and 70 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of at least one year
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
ability to understand and willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HER2 Protein Overexpression Immunohistochemistry | HER2 gene amplification FISH
Item
her2 3+ over-expression on immunohistochemistry (ihc), or her2 amplification on fluorescence in situ hybridization (fish) study
boolean
C1515560 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Malignancy Systemic | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Disease Free Time Interval
Item
previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years
boolean
C0006826 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
C0872291 (UMLS CUI [4,4])
Prior Chemotherapy
Item
patients who have received prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement
Item
inadequate hematological function defined as absolute neutrophil count (anc)less than 1,500/mm3, and platelets less than 100,000/mm3
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver function Inadequate | Serum bilirubin increased | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
inadequate hepatic function defined as: serum bilirubin greater than 1.5 times the upper limit of normal range (uln) alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 2.5 times the uln
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0859062 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Renal function Inadequate | Serum creatinine raised
Item
inadequate renal function defined as serum creatinine greater than 1.5 times the uln
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0700225 (UMLS CUI [2])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
left ventricular ejection fraction (lvef) < 50% confirmed by multiple-gated acquisition (muga) scan or echocardiogram
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Comorbidity Aggregation Due to Chemotherapy | Comorbidity Interferes with Study Assessment | Communicable Disease Uncontrolled | Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis | Disease Uncontrolled | Congestive heart failure | Myocardial Ischemia | Uncontrolled hypertension | Cardiac Arrhythmia | Unstable diabetes mellitus | Peptic Ulcer
Item
concomitant illness that might be aggregated by chemotherapy or interfere study assessment. for examples, active, non- controlled infection (such as hepatitis b and hepatitis c, hiv, infectious tuberculosis) or other active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia, unstable diabetes mellitus, and active peptic ulcer
boolean
C0009488 (UMLS CUI [1,1])
C0332621 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
C0041296 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C0018802 (UMLS CUI [9])
C0151744 (UMLS CUI [10])
C1868885 (UMLS CUI [11])
C0003811 (UMLS CUI [12])
C0342302 (UMLS CUI [13])
C0030920 (UMLS CUI [14])
Liver Cirrhosis | Hepatitis B carrier | Hepatitis C carrier
Item
patients who are presence of liver cirrhosis or are hbv/hcv carrier
boolean
C0023890 (UMLS CUI [1])
C0262505 (UMLS CUI [2])
C0400920 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in another clinical trial with any investigational drug within 30 days prior to entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Exception Use of Contraceptive methods
Item
fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
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