ID

32482

Beskrivning

Assessment of Cardiotoxicity by Cardiac Magnetic Resonance (CMR) in Breast Cancer Patients Receiving Trastuzumab; ODM derived from: https://clinicaltrials.gov/show/NCT01022086

Länk

https://clinicaltrials.gov/show/NCT01022086

Nyckelord

Versioner (1)
  1. 2018-11-03 2018-11-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 november 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Stage I-IV Breast Cancer (Neo-adjuvant, Adjuvant, Locally Advanced and Metastatic) NCT01022086

Engelsk

Eligibility Stage I-IV Breast Cancer (Neo-adjuvant, Adjuvant, Locally Advanced and Metastatic) NCT01022086

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
histologically confirmed diagnosis of invasive breast carcinoma
Beskrivning

Invasive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0853879
histologically confirmed her2 overexpression using ihc and/or fish and/or dish
Beskrivning

HER2 Overexpression Immunohistochemistry | HER2 Overexpression FISH | HER2 Overexpression In Situ Hybridization Dual

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1514559
UMLS CUI [2,3]
C0162789
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C1514559
UMLS CUI [3,3]
C0162788
UMLS CUI [3,4]
C0205173
planned treatment with trastuzumab or tdm-1
Beskrivning

Trastuzumab Planned | T-DM1 Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C2935436
UMLS CUI [2,2]
C1301732
baseline lvef >50% by muga (echos or any other type of cardiac scanning may be done as part of standard clinical care, at the investigator's discretion; echos cannot be done in place of muga scans)
Beskrivning

LVEF MUGA scan | LVEF Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with trastuzumab or any other anti-her2 agent (e.g. lapatinib, pertuzumab, etc.)
Beskrivning

Trastuzumab Prior Therapy | HER2 Inhibitor Prior Therapy | lapatinib | pertuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C0069515
UMLS CUI [2,2]
C1999216
UMLS CUI [2,3]
C1514463
UMLS CUI [3]
C1506770
UMLS CUI [4]
C1328025
pre-existing symptomatic heart failure (nyha class iii or iv)
Beskrivning

Heart failure Symptomatic Pre-existing New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C1275491
recent acute coronary syndrome (myocardial infarction, unstable angina) within the last six months
Beskrivning

Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
recent coronary revascularization (percutaneous coronary intervention or coronary bypass surgery) within six months
Beskrivning

Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0010055
permanent atrial fibrillation
Beskrivning

Permanent atrial fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C2586056
inability to undergo mri (shrapnel, metallic implants/clips, pacemaker or defibrillator)
Beskrivning

MRI Receive Unable | Shrapnel | Metallic implant | Clip | Artificial cardiac pacemaker | Defibrillators

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0522670
UMLS CUI [3]
C3693688
UMLS CUI [4]
C0175722
UMLS CUI [5]
C0030163
UMLS CUI [6]
C0180307
currently pregnant and/or nursing
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
planned or current use of other targeted biological therapies that can potentially cause cardiotoxicity (i.e. bevacizumab)
Beskrivning

Targeted Therapy biological Causing Cardiotoxicity | bevacizumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0205460
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0876994
UMLS CUI [2]
C0796392
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Similar models

Eligibility Stage I-IV Breast Cancer (Neo-adjuvant, Adjuvant, Locally Advanced and Metastatic) NCT01022086

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Invasive carcinoma of breast
Item
histologically confirmed diagnosis of invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
HER2 Overexpression Immunohistochemistry | HER2 Overexpression FISH | HER2 Overexpression In Situ Hybridization Dual
Item
histologically confirmed her2 overexpression using ihc and/or fish and/or dish
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0069515 (UMLS CUI [2,1])
C1514559 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C0069515 (UMLS CUI [3,1])
C1514559 (UMLS CUI [3,2])
C0162788 (UMLS CUI [3,3])
C0205173 (UMLS CUI [3,4])
Trastuzumab Planned | T-DM1 Planned
Item
planned treatment with trastuzumab or tdm-1
boolean
C0728747 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C2935436 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
LVEF MUGA scan | LVEF Echocardiography
Item
baseline lvef >50% by muga (echos or any other type of cardiac scanning may be done as part of standard clinical care, at the investigator's discretion; echos cannot be done in place of muga scans)
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Trastuzumab Prior Therapy | HER2 Inhibitor Prior Therapy | lapatinib | pertuzumab
Item
previous treatment with trastuzumab or any other anti-her2 agent (e.g. lapatinib, pertuzumab, etc.)
boolean
C0728747 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0069515 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C1506770 (UMLS CUI [3])
C1328025 (UMLS CUI [4])
Heart failure Symptomatic Pre-existing New York Heart Association Classification
Item
pre-existing symptomatic heart failure (nyha class iii or iv)
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1275491 (UMLS CUI [1,4])
Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable
Item
recent acute coronary syndrome (myocardial infarction, unstable angina) within the last six months
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
recent coronary revascularization (percutaneous coronary intervention or coronary bypass surgery) within six months
boolean
C0877341 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
Permanent atrial fibrillation
Item
permanent atrial fibrillation
boolean
C2586056 (UMLS CUI [1])
MRI Receive Unable | Shrapnel | Metallic implant | Clip | Artificial cardiac pacemaker | Defibrillators
Item
inability to undergo mri (shrapnel, metallic implants/clips, pacemaker or defibrillator)
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0522670 (UMLS CUI [2])
C3693688 (UMLS CUI [3])
C0175722 (UMLS CUI [4])
C0030163 (UMLS CUI [5])
C0180307 (UMLS CUI [6])
Pregnancy | Breast Feeding
Item
currently pregnant and/or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Targeted Therapy biological Causing Cardiotoxicity | bevacizumab
Item
planned or current use of other targeted biological therapies that can potentially cause cardiotoxicity (i.e. bevacizumab)
boolean
C2985566 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0876994 (UMLS CUI [1,4])
C0796392 (UMLS CUI [2])
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