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Falhas:
ID
43540
Descrição
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
Palavras-chave
Versões (2)
- 23/10/2017 23/10/2017 -
- 20/09/2021 20/09/2021 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
20 de setembro de 2021
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00875238
Eligibility Breast Cancer NCT00875238
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00875238
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0282564 (UMLS CUI [2])