ID

37863

Beschrijving

Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01153282

Link

https://clinicaltrials.gov/show/NCT01153282

Trefwoorden

Versies (2)
  1. 28-08-19 28-08-19 -
  2. 28-08-19 28-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01153282

Engels

Eligibility Breast Cancer NCT01153282

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 21-70 years old (women over 70 are offered chemotherapy less frequently because of their risk benefit ratio. including them would be a selection bias because of their differential underexposure).
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously untreated metastatic setting.
Beschrijving

Taxane | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Neoplasm Metastasis Untreated

Datatype

boolean

Alias
UMLS CUI [1]
C0215136
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [3]
C0085533
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0332155
the range of exposure to taxane-based chemotherapy will include women on active treatment having received two cycles, to women who are within three months of their last infusion.
Beschrijving

Exposure to Taxane Chemotherapy | Chemotherapy cycle Quantity | Timespan Infusion Last

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0215136
UMLS CUI [1,3]
C3665472
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0872291
UMLS CUI [3,2]
C0574032
UMLS CUI [3,3]
C1517741
documented symptoms of cipn per ctcae grading criteria (half of sample) or no symptoms (half of sample) grade 0 = no cipn symptoms grade 1 = mild symptoms grade 2 = moderate symptoms - prescribed gabapentin (neurontin) grade 3&4= severe symptoms -
Beschrijving

Symptoms Chemotherapy-induced peripheral neuropathy CTCAE Grades | Symptoms Absent | gabapentin | Neurontin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3873567
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0060926
UMLS CUI [4]
C0678176
treated with gabapentin (neurontin), treatment plan altered
Beschrijving

Gabapentin | Neurontin | Treatment Plan altered

Datatype

boolean

Alias
UMLS CUI [1]
C0060926
UMLS CUI [2]
C0678176
UMLS CUI [3,1]
C0599880
UMLS CUI [3,2]
C0392747
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
physical disabilities - defined by use of assistive devices to complete functional tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy.
Beschrijving

Physical disability | Use of Assistive Devices | Wheelchair | Crutches | Limb Prosthesis

Datatype

boolean

Alias
UMLS CUI [1]
C0520817
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0036605
UMLS CUI [3]
C0043143
UMLS CUI [4]
C0010397
UMLS CUI [5]
C0347948
current exposure to neurotoxic agents (navelbine, platinums or other taxanes)
Beschrijving

Exposure to Neurotoxic agents | Navelbine | Platinum | Taxanes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0260049
UMLS CUI [2]
C0131965
UMLS CUI [3]
C0032207
UMLS CUI [4]
C0796419
pregnancy during chemotherapy treatment
Beschrijving

Pregnancy During Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0392920
diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically established neuropathy
Beschrijving

Diabetes Mellitus Disease length | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus With Neuropathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0011854
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0442874
previous exposure to chemotherapy or radiotherapy
Beschrijving

Exposure to Chemotherapy | Exposure to Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1522449
hiv positive (high risk for neuropathy)
Beschrijving

HIV Seropositivity | High risk of Neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0442874
other neurological diseases, such as multiple sclerosis
Beschrijving

Nervous system disorder | Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0026769
other pre-existing neuropathy
Beschrijving

Neuropathy Pre-existing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
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Similar models

Eligibility Breast Cancer NCT01153282

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women 21-70 years old (women over 70 are offered chemotherapy less frequently because of their risk benefit ratio. including them would be a selection bias because of their differential underexposure).
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Taxane | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Neoplasm Metastasis Untreated
Item
initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously untreated metastatic setting.
boolean
C0215136 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
C0027627 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
Exposure to Taxane Chemotherapy | Chemotherapy cycle Quantity | Timespan Infusion Last
Item
the range of exposure to taxane-based chemotherapy will include women on active treatment having received two cycles, to women who are within three months of their last infusion.
boolean
C0332157 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0872291 (UMLS CUI [3,1])
C0574032 (UMLS CUI [3,2])
C1517741 (UMLS CUI [3,3])
Symptoms Chemotherapy-induced peripheral neuropathy CTCAE Grades | Symptoms Absent | gabapentin | Neurontin
Item
documented symptoms of cipn per ctcae grading criteria (half of sample) or no symptoms (half of sample) grade 0 = no cipn symptoms grade 1 = mild symptoms grade 2 = moderate symptoms - prescribed gabapentin (neurontin) grade 3&4= severe symptoms -
boolean
C1457887 (UMLS CUI [1,1])
C3873567 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0060926 (UMLS CUI [3])
C0678176 (UMLS CUI [4])
Gabapentin | Neurontin | Treatment Plan altered
Item
treated with gabapentin (neurontin), treatment plan altered
boolean
C0060926 (UMLS CUI [1])
C0678176 (UMLS CUI [2])
C0599880 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Physical disability | Use of Assistive Devices | Wheelchair | Crutches | Limb Prosthesis
Item
physical disabilities - defined by use of assistive devices to complete functional tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy.
boolean
C0520817 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0036605 (UMLS CUI [2,2])
C0043143 (UMLS CUI [3])
C0010397 (UMLS CUI [4])
C0347948 (UMLS CUI [5])
Exposure to Neurotoxic agents | Navelbine | Platinum | Taxanes
Item
current exposure to neurotoxic agents (navelbine, platinums or other taxanes)
boolean
C0332157 (UMLS CUI [1,1])
C0260049 (UMLS CUI [1,2])
C0131965 (UMLS CUI [2])
C0032207 (UMLS CUI [3])
C0796419 (UMLS CUI [4])
Pregnancy During Chemotherapy
Item
pregnancy during chemotherapy treatment
boolean
C0032961 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Diabetes Mellitus Disease length | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus With Neuropathy
Item
diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically established neuropathy
boolean
C0011849 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011854 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0442874 (UMLS CUI [3,3])
Exposure to Chemotherapy | Exposure to Therapeutic radiology procedure
Item
previous exposure to chemotherapy or radiotherapy
boolean
C0332157 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
HIV Seropositivity | High risk of Neuropathy
Item
hiv positive (high risk for neuropathy)
boolean
C0019699 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0442874 (UMLS CUI [2,2])
Nervous system disorder | Multiple Sclerosis
Item
other neurological diseases, such as multiple sclerosis
boolean
C0027765 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Neuropathy Pre-existing
Item
other pre-existing neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
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