ID

43540

Description

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

Lien

https://clinicaltrials.gov/show/NCT00875238

Mots-clés

Versions (2)
  1. 23/10/2017 23/10/2017 -
  2. 20/09/2021 20/09/2021 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

20 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00875238

Anglais

Eligibility Breast Cancer NCT00875238

1 Formulaires  
Criteria
Description

Criteria

diagnosed with breast cancer
Description

Breast Carcinoma

Type de données

boolean

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

Therapeutic procedure Oncology Center

Type de données

boolean

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

Doxorubicin Hydrochloride Course Quantity

Type de données

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)
Description

Trastuzumab Scheduled

Type de données

boolean

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

Neoplasm Metastasis Absent

Type de données

boolean

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

Hormone Receptor Status Unspecified

Type de données

boolean

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

Client Characteristics

Type de données

boolean

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

Menopausal Status Unspecified

Type de données

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
karnofsky performance status 60-100%
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
not pregnant
Description

Pregnancy Absent

Type de données

boolean

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

Pregnancy test negative

Type de données

boolean

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

Criteria Additional | MRI

Type de données

boolean

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

Glomerular Filtration Rate

Type de données

boolean

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

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

Type de données

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
Description

Exclusion | Adverse reaction Gadolinium-based Contrast Agent

Type de données

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
Description

Normal weight | Normal height | Patient Appropriate MRI Scanner

Type de données

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:
Description

Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.18

Type de données

boolean

no prior anthracycline chemotherapy
Description

Exclusion | Anthracyclines

Type de données

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0282564
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT00875238

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
C3829127 (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])
Retour au début de la page 

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