ID

26015

Beskrivning

Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00427427

Länk

https://clinicaltrials.gov/show/NCT00427427

Nyckelord

Versioner (2)
  1. 2017-10-02 2017-10-02 -
  2. 2017-10-04 2017-10-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00427427

Engelsk

Eligibility Breast Cancer NCT00427427

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed non-metastatic infiltrating carcinoma of the breast.
Beskrivning

Infiltrating carcinoma of breast Without Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0027627
2. her-2 amplified (fish +) determination in 2004 or thereafter.
Beskrivning

HER2 gene amplification FISH Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512127
UMLS CUI [1,2]
C0162789
UMLS CUI [1,3]
C1514241
3. ecog performance status 0-2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. patients 18 years of age or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. her-2 status is determined by fish test.
Beskrivning

HER2/Neu Status FISH test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0162789
6. the following criteria are applicable to the trastuzumab treatment group:
Beskrivning

Criteria Trastuzumab Group

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0728747
UMLS CUI [1,3]
C0441833
normal lvef as determined by echo or muga. if baseline lvef > 75%, then lvef shall be repeated to determine if falsely elevated.
Beskrivning

LVEF Normal Echocardiography | LVEF Normal MUGA | Baseline LVEF

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0205307
UMLS CUI [2,3]
C0521317
UMLS CUI [3,1]
C1442488
UMLS CUI [3,2]
C0428772
adequate bone marrow function as indicated by the following: anc >1500/ml, platelets >/=100,000/ml, hemoglobin >9 g/dl
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
adequate renal function,as indicated by serum creatinine </= 1.5 x uln
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
adequate liver function, as indicated by total bilirubin </= 1.5 x uln
Beskrivning

Liver function | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
ast and alt < 2 x uln unless related to primary disease.
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Relationship Primary disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0277554
if female of childbearing potential, pregnancy test (blood or urine) is negative and she agrees to use effective birth control method for the duration of the study.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
7. signed informed consent has been obtained.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. non-confirmed her-2 positive by fish infiltrating carcinoma of the breast.
Beskrivning

Infiltrating carcinoma of breast | FISH HER2/Neu Positive Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0162789
UMLS CUI [2,2]
C2348909
UMLS CUI [2,3]
C0332268
2. evidence of metastatic disease.
Beskrivning

Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
3. previous trastuzumab treatment.
Beskrivning

Trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0728747
4. concurrent anticancer treatment other than hormonal agents (tamoxifen, aromatase inhibitors) or radiotherapy.
Beskrivning

Cancer treatment | Exception Hormonal Agents | Exception Tamoxifen | Exception Aromatase Inhibitors | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0282559
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0039286
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0593802
UMLS CUI [5]
C1522449
5. patient with history of or active cardiac disease, including cardiomyopathy, congestive heart failure, prior myocardial infarction, or arrhythmia.
Beskrivning

Heart Disease | Cardiomyopathy | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0878544
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0003811
6. symptomatic intrinsic lung disease resulting in dyspnea at rest.
Beskrivning

Lung disease Intrinsic Symptomatic | Resting Dyspnea

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205102
UMLS CUI [1,3]
C0231220
UMLS CUI [2]
C0743330
7. concurrent life-limiting disease with a life expectancy of less than one year.
Beskrivning

Disease Life Limiting | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0376558
UMLS CUI [1,3]
C0439801
UMLS CUI [2]
C0023671
8. pregnancy, nursing women, and fertile women who do not practice birth control.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
9. inability to give informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Breast Cancer NCT00427427

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Infiltrating carcinoma of breast Without Neoplasm Metastasis
Item
1. confirmed non-metastatic infiltrating carcinoma of the breast.
boolean
C0853879 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
HER2 gene amplification FISH Positive
Item
2. her-2 amplified (fish +) determination in 2004 or thereafter.
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
ECOG performance status
Item
3. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Age
Item
4. patients 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
HER2/Neu Status FISH test
Item
5. her-2 status is determined by fish test.
boolean
C1512413 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
Criteria Trastuzumab Group
Item
6. the following criteria are applicable to the trastuzumab treatment group:
boolean
C0243161 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
LVEF Normal Echocardiography | LVEF Normal MUGA | Baseline LVEF
Item
normal lvef as determined by echo or muga. if baseline lvef > 75%, then lvef shall be repeated to determine if falsely elevated.
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0521317 (UMLS CUI [2,3])
C1442488 (UMLS CUI [3,1])
C0428772 (UMLS CUI [3,2])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow function as indicated by the following: anc >1500/ml, platelets >/=100,000/ml, hemoglobin >9 g/dl
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
adequate renal function,as indicated by serum creatinine </= 1.5 x uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement
Item
adequate liver function, as indicated by total bilirubin </= 1.5 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Relationship Primary disease
Item
ast and alt < 2 x uln unless related to primary disease.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0277554 (UMLS CUI [3,3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
if female of childbearing potential, pregnancy test (blood or urine) is negative and she agrees to use effective birth control method for the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Informed Consent
Item
7. signed informed consent has been obtained.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Infiltrating carcinoma of breast | FISH HER2/Neu Positive Lacking
Item
1. non-confirmed her-2 positive by fish infiltrating carcinoma of the breast.
boolean
C0853879 (UMLS CUI [1])
C0162789 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Neoplasm Metastasis
Item
2. evidence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Trastuzumab
Item
3. previous trastuzumab treatment.
boolean
C0728747 (UMLS CUI [1])
Cancer treatment | Exception Hormonal Agents | Exception Tamoxifen | Exception Aromatase Inhibitors | Therapeutic radiology procedure
Item
4. concurrent anticancer treatment other than hormonal agents (tamoxifen, aromatase inhibitors) or radiotherapy.
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0282559 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0039286 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0593802 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5])
Heart Disease | Cardiomyopathy | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia
Item
5. patient with history of or active cardiac disease, including cardiomyopathy, congestive heart failure, prior myocardial infarction, or arrhythmia.
boolean
C0018799 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
Lung disease Intrinsic Symptomatic | Resting Dyspnea
Item
6. symptomatic intrinsic lung disease resulting in dyspnea at rest.
boolean
C0024115 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0743330 (UMLS CUI [2])
Disease Life Limiting | Life Expectancy
Item
7. concurrent life-limiting disease with a life expectancy of less than one year.
boolean
C0012634 (UMLS CUI [1,1])
C0376558 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0023671 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
8. pregnancy, nursing women, and fertile women who do not practice birth control.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Informed Consent Unable
Item
9. inability to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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