ID

26667

Beschrijving

Side Effects Involving the Heart in Women With Breast Cancer Receiving Doxorubicin and Trastuzumab; ODM derived from: https://clinicaltrials.gov/show/NCT00875238

Link

https://clinicaltrials.gov/show/NCT00875238

Trefwoorden

Versies (2)
  1. 23-10-17 23-10-17 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00875238

Engels

Eligibility Breast Cancer NCT00875238

1 Formulieren  
Criteria
Beschrijving

Criteria

diagnosed with breast cancer
Beschrijving

Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
receiving treatment at vanderbilt ingram cancer center and other participating oncology practices in middle tennessee and southern kentucky
Beschrijving

Therapeutic procedure Oncology Center

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1552534
starting a standard doxorubicin hydrochloride regimen for 4 courses
Beschrijving

Doxorubicin Hydrochloride Course Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0546861
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
also scheduled to receive trastuzumab (for patients enrolled in sub-study b only)
Beschrijving

Trastuzumab Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0205539
no presence of metastatic disease
Beschrijving

Neoplasm Metastasis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
hormone receptor status not specified
Beschrijving

Hormone Receptor Status Unspecified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Beschrijving

Menopausal Status Unspecified

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513126
UMLS CUI [1,2]
C0205370
karnofsky performance status 60-100%
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
not pregnant
Beschrijving

Pregnancy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
negative pregnancy test
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
additional criteria for sub-study a (mri):
Beschrijving

Criteria Additional | MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
UMLS CUI [2]
C0024485
glomerular filtration rate ≥ 60 ml/min
Beschrijving

Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0017654
no implanted electronic devices, cochlear implants, metallic implants, shrapnel or neurosurgical clips
Beschrijving

Exclusion Criteria | Implanted medical device Electronic | Cochlear Implants | metallic implant | Shrapnel | Clips Neurosurgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C2735362
UMLS CUI [2,2]
C0013850
UMLS CUI [3]
C0009199
UMLS CUI [4]
C3693688
UMLS CUI [5]
C0522670
UMLS CUI [6,1]
C0038917
UMLS CUI [6,2]
C0524850
no prior adverse reaction to gadolinium-based contrast agents
Beschrijving

Exclusion | Adverse reaction Gadolinium-based Contrast Agent

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C3249258
must not exceed the weight limit or be too large to fit in the mri scanner
Beschrijving

Normal weight | Normal height | Patient Appropriate MRI Scanner

Datatype

boolean

Alias
UMLS CUI [1]
C2712185
UMLS CUI [2]
C0587053
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0024485
UMLS CUI [3,4]
C1710020
prior concurrent therapy:
Beschrijving

Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beschrijving

ID.18

Datatype

boolean

no prior anthracycline chemotherapy
Beschrijving

Exclusion | Anthracyclines

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0282564
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Similar models

Eligibility Breast Cancer NCT00875238

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Breast Carcinoma
Item
diagnosed with breast cancer
boolean
C0678222 (UMLS CUI [1])
Therapeutic procedure Oncology Center
Item
receiving treatment at vanderbilt ingram cancer center and other participating oncology practices in middle tennessee and southern kentucky
boolean
C0087111 (UMLS CUI [1,1])
C1552534 (UMLS CUI [1,2])
Doxorubicin Hydrochloride Course Quantity
Item
starting a standard doxorubicin hydrochloride regimen for 4 courses
boolean
C0546861 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Trastuzumab Scheduled
Item
also scheduled to receive trastuzumab (for patients enrolled in sub-study b only)
boolean
C0728747 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Neoplasm Metastasis Absent
Item
no presence of metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C1513126 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
karnofsky performance status 60-100%
boolean
C0206065 (UMLS CUI [1])
Pregnancy Absent
Item
not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Criteria Additional | MRI
Item
additional criteria for sub-study a (mri):
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2])
Glomerular Filtration Rate
Item
glomerular filtration rate ≥ 60 ml/min
boolean
C0017654 (UMLS CUI [1])
Exclusion Criteria | Implanted medical device Electronic | Cochlear Implants | metallic implant | Shrapnel | Clips Neurosurgical Procedures
Item
no implanted electronic devices, cochlear implants, metallic implants, shrapnel or neurosurgical clips
boolean
C0680251 (UMLS CUI [1])
C2735362 (UMLS CUI [2,1])
C0013850 (UMLS CUI [2,2])
C0009199 (UMLS CUI [3])
C3693688 (UMLS CUI [4])
C0522670 (UMLS CUI [5])
C0038917 (UMLS CUI [6,1])
C0524850 (UMLS CUI [6,2])
Exclusion | Adverse reaction Gadolinium-based Contrast Agent
Item
no prior adverse reaction to gadolinium-based contrast agents
boolean
C2828389 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C3249258 (UMLS CUI [2,2])
Normal weight | Normal height | Patient Appropriate MRI Scanner
Item
must not exceed the weight limit or be too large to fit in the mri scanner
boolean
C2712185 (UMLS CUI [1])
C0587053 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C1710020 (UMLS CUI [3,4])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.18
Item
see disease characteristics
boolean
Exclusion | Anthracyclines
Item
no prior anthracycline chemotherapy
boolean
C2828389 (UMLS CUI [1])
C0282564 (UMLS CUI [2])
Terug naar het begin van de pagina 

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