ID

37763

Description

Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00916877

Link

https://clinicaltrials.gov/show/NCT00916877

Keywords

Versions (1)
  1. 8/22/19 8/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00916877

English

Eligibility Breast Cancer NCT00916877

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female with her2-positive disease
Description

Gender | Disease HER2 Positive

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348909
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog greater or equal to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy greater or equal to 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
able to complete self administered quality of life evaluations and neurocognitive testing
Description

Quality of life Evaluation Self-Administered | Testing neurocognitive

Data type

boolean

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C1519231
UMLS CUI [2,1]
C0039593
UMLS CUI [2,2]
C0518895
willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
Description

Compliance Clinical Trial Instructions | Commitment Clinic Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1442085
UMLS CUI [2,1]
C0870312
UMLS CUI [2,2]
C0008952
women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit and must use highly effective birth control during study
Description

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

Data type

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
signed informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current malignancy in the brain, as determined by screening mri/ct done no more then 6 weeks prior to study treatment with pci
Description

Brain Neoplasm MRI | Brain Neoplasm CT

Data type

boolean

Alias
UMLS CUI [1,1]
C0006118
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0006118
UMLS CUI [2,2]
C0040405
chemo or radiation planned during the period when patients will receive study treatment with pci
Description

Chemotherapy Planned | Therapeutic radiology procedure Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1301732
prior radiotherapy of the brain
Description

Radiotherapy to brain

Data type

boolean

Alias
UMLS CUI [1]
C0948319
prior stroke or brain hemorrhage in the 6 months prior to screening
Description

Cerebrovascular accident | Brain hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0553692
history of neurological/psychiatric disorders, including psychotic disorders or demential, or any other reason, which may affect neurocognitive assessment
Description

Nervous system disorder Affecting Assessment neurocognitive | Mental disorders Affecting Assessment neurocognitive | Psychotic Disorders Affecting Assessment neurocognitive | Dementia disorder Affecting Assessment neurocognitive | Condition Affecting Assessment neurocognitive

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0518895
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C1516048
UMLS CUI [2,4]
C0518895
UMLS CUI [3,1]
C0033975
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1516048
UMLS CUI [3,4]
C0518895
UMLS CUI [4,1]
C0497327
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1516048
UMLS CUI [4,4]
C0518895
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C1516048
UMLS CUI [5,4]
C0518895
inadequate renal function
Description

Renal function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
other known previous or concomitant serious illness or medical condition that may interfere with participation in the study
Description

Illness Serious Interferes with Study Subject Participation Status | Comorbidity Serious Interferes with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
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Similar models

Eligibility Breast Cancer NCT00916877

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Disease HER2 Positive
Item
female with her2-positive disease
boolean
C0079399 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog greater or equal to 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater or equal to 6 months
boolean
C0023671 (UMLS CUI [1])
Quality of life Evaluation Self-Administered | Testing neurocognitive
Item
able to complete self administered quality of life evaluations and neurocognitive testing
boolean
C0034380 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C1519231 (UMLS CUI [1,3])
C0039593 (UMLS CUI [2,1])
C0518895 (UMLS CUI [2,2])
Compliance Clinical Trial Instructions | Commitment Clinic Visits
Item
willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
boolean
C1321605 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
C0870312 (UMLS CUI [2,1])
C0008952 (UMLS CUI [2,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit and must use highly effective birth control during 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
signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Brain Neoplasm MRI | Brain Neoplasm CT
Item
current malignancy in the brain, as determined by screening mri/ct done no more then 6 weeks prior to study treatment with pci
boolean
C0006118 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0006118 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Chemotherapy Planned | Therapeutic radiology procedure Planned
Item
chemo or radiation planned during the period when patients will receive study treatment with pci
boolean
C0392920 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Radiotherapy to brain
Item
prior radiotherapy of the brain
boolean
C0948319 (UMLS CUI [1])
Cerebrovascular accident | Brain hemorrhage
Item
prior stroke or brain hemorrhage in the 6 months prior to screening
boolean
C0038454 (UMLS CUI [1])
C0553692 (UMLS CUI [2])
Nervous system disorder Affecting Assessment neurocognitive | Mental disorders Affecting Assessment neurocognitive | Psychotic Disorders Affecting Assessment neurocognitive | Dementia disorder Affecting Assessment neurocognitive | Condition Affecting Assessment neurocognitive
Item
history of neurological/psychiatric disorders, including psychotic disorders or demential, or any other reason, which may affect neurocognitive assessment
boolean
C0027765 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0518895 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0518895 (UMLS CUI [2,4])
C0033975 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C0518895 (UMLS CUI [3,4])
C0497327 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
C0518895 (UMLS CUI [4,4])
C0348080 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C1516048 (UMLS CUI [5,3])
C0518895 (UMLS CUI [5,4])
Renal function Inadequate
Item
inadequate renal function
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Illness Serious Interferes with Study Subject Participation Status | Comorbidity Serious Interferes with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status
Item
other known previous or concomitant serious illness or medical condition that may interfere with participation in the study
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
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