ID

35033

Beschrijving

Effect of GM1 in Prevention of Taxanes Induced Neurotoxicity in Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02468739

Link

https://clinicaltrials.gov/show/NCT02468739

Trefwoorden

Versies (1)
  1. 11-02-19 11-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02468739

Engels

Eligibility Breast Cancer NCT02468739

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18-65 years old, female
Beschrijving

Age | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
histologically confirmed diagnosis of invasive adenocarcinoma
Beschrijving

Adenocarcinoma Invasive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C0205281
intends to receive at least 4 cycles taxanes-based adjuvant chemotherapy
Beschrijving

taxane | Chemotherapy cycle Adjuvant Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0215136
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C1265611
prior any level of peripheral nerve system disease
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
with the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
Beschrijving

Neurotoxicity Questionnaire Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
with normal functions of major organs
Beschrijving

Organ Major Function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0031843
no contraindication to chemotherapy
Beschrijving

Medical contraindication Absent Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0392920
patients have provided a signed informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients are expected not be able to complete adjuvant chemotherapy
Beschrijving

Adjuvant Chemotherapy Completion Unlikely

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0750558
be allergic to gm1
Beschrijving

Hypersensitivity GM1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016895
hereditary abnormal metabolism of glucose and lipid
Beschrijving

Glucose metabolism abnormal Hereditary | Lipid Metabolism Abnormal Hereditary

Datatype

boolean

Alias
UMLS CUI [1,1]
C1142273
UMLS CUI [1,2]
C0439660
UMLS CUI [2,1]
C0598783
UMLS CUI [2,2]
C0205161
UMLS CUI [2,3]
C0439660
doctors believe that patients are not suitable for receiving gm1 treatment
Beschrijving

Patients Inappropriate GM1 Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0016895
UMLS CUI [1,4]
C0087111
with confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
Beschrijving

Nervous system disorder | Mental disorders | Epilepsy | Dementia

Datatype

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0497327
with concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
Beschrijving

Comorbidity Affecting Patient safety | Comorbidity Impact Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C2732579
patients have fertility possibility but not willing or not to take effective contraceptive measures
Beschrijving

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Breast Cancer NCT02468739

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender
Item
age: 18-65 years old, female
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Adenocarcinoma Invasive
Item
histologically confirmed diagnosis of invasive adenocarcinoma
boolean
C0001418 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
taxane | Chemotherapy cycle Adjuvant Quantity
Item
intends to receive at least 4 cycles taxanes-based adjuvant chemotherapy
boolean
C0215136 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Peripheral Neuropathy CTCAE Grades
Item
prior any level of peripheral nerve system disease
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Neurotoxicity Questionnaire Completion
Item
with the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
boolean
C0235032 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Organ Major Function
Item
with normal functions of major organs
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
Medical contraindication Absent Chemotherapy
Item
no contraindication to chemotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Informed Consent
Item
patients have provided a signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adjuvant Chemotherapy Completion Unlikely
Item
patients are expected not be able to complete adjuvant chemotherapy
boolean
C0085533 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
Hypersensitivity GM1
Item
be allergic to gm1
boolean
C0020517 (UMLS CUI [1,1])
C0016895 (UMLS CUI [1,2])
Glucose metabolism abnormal Hereditary | Lipid Metabolism Abnormal Hereditary
Item
hereditary abnormal metabolism of glucose and lipid
boolean
C1142273 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0598783 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0439660 (UMLS CUI [2,3])
Patients Inappropriate GM1 Therapy
Item
doctors believe that patients are not suitable for receiving gm1 treatment
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0016895 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Nervous system disorder | Mental disorders | Epilepsy | Dementia
Item
with confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
Comorbidity Affecting Patient safety | Comorbidity Impact Completion of clinical trial
Item
with concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
patients have fertility possibility but not willing or not to take effective contraceptive measures
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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