ID

37863

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01153282

Stichworte

Versionen (2)
  1. 28.08.19 28.08.19 -
  2. 28.08.19 28.08.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. August 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT01153282

Englisch

Eligibility Breast Cancer NCT01153282

1 Formulare  
Inclusion Criteria
Beschreibung

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).
Beschreibung

Gender | Age

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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 -
Beschreibung

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

Datentyp

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
Beschreibung

Gabapentin | Neurontin | Treatment Plan altered

Datentyp

boolean

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

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.
Beschreibung

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

Datentyp

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)
Beschreibung

Exposure to Neurotoxic agents | Navelbine | Platinum | Taxanes

Datentyp

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
Beschreibung

Pregnancy During Chemotherapy

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Exposure to Chemotherapy | Exposure to Therapeutic radiology procedure

Datentyp

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)
Beschreibung

HIV Seropositivity | High risk of Neuropathy

Datentyp

boolean

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

Nervous system disorder | Multiple Sclerosis

Datentyp

boolean

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

Neuropathy Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT01153282

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video