ID

38192

Beschrijving

Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02125019

Link

https://clinicaltrials.gov/show/NCT02125019

Trefwoorden

Versies (1)
  1. 25-09-19 25-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 september 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02125019

Engels

Eligibility Breast Cancer NCT02125019

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients (men and women) diagnosed with breast cancer stages i-iii initiating first line adjuvant or neoadjuvant therapy with paclitaxel or docetaxel
Beschrijving

Breast Carcinoma TNM Breast tumor staging | First line Adjuvant therapy | First line Neoadjuvant Therapy | Paclitaxel | docetaxel

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C1708063
UMLS CUI [3,2]
C0600558
UMLS CUI [4]
C0144576
UMLS CUI [5]
C0246415
ability to understand and the willingness to sign a written informed consent document.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients with functional limitations due to musculoskeletal conditions can be included, because these conditions are known to remain stable over the relatively short duration of the study.
Beschrijving

Functional Limitation Due to Musculoskeletal problem

Datatype

boolean

Alias
UMLS CUI [1,1]
C4542603
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0026859
concurrent standard and investigational agents are permissible with the standard chemotherapy drugs.
Beschrijving

Standard Pharmaceutical Preparations | Investigational New Drugs | Standard Chemotherapeutic Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1442989
UMLS CUI [3,2]
C0003392
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior known chemotherapy or targeted therapy (for breast cancer or other malignancies that is known to be associated with neuropathy in the last 12 months(platinum therapy, bortezomib, vinblastine, etc.)
Beschrijving

Prior Chemotherapy Breast Carcinoma | Targeted Therapy Breast Carcinoma | Prior Chemotherapy Cancer Other Associated with Neuropathy | Targeted Therapy Cancer Other Associated with Neuropathy | Platinum Therapy | bortezomib | Vinblastine

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C1707251
UMLS CUI [3,3]
C0332281
UMLS CUI [3,4]
C0442874
UMLS CUI [4,1]
C2985566
UMLS CUI [4,2]
C1707251
UMLS CUI [4,3]
C0332281
UMLS CUI [4,4]
C0442874
UMLS CUI [5,1]
C0032207
UMLS CUI [5,2]
C0087111
UMLS CUI [6]
C1176309
UMLS CUI [7]
C0042670
prior taxane exposure at any time
Beschrijving

Exposure to Taxane

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0215136
preexisting known diagnosis of any type of neuropathy prior to start of paclitaxel or docetaxel chemotherapy
Beschrijving

Neuropathy Type Any

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
pregnant or nursing women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unable to give informed consent.
Beschrijving

Informed Consent Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
preexisting lower extremity amputation
Beschrijving

Amputation of lower limb Pre-existing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0337308
UMLS CUI [1,2]
C2347662
inability to walk or stand without assistance due to any condition
Beschrijving

Difficulty walking unassisted | Lacking Able to stand alone | Etiology Condition Any

Datatype

boolean

Alias
UMLS CUI [1]
C2183457
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0560202
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0348080
UMLS CUI [3,3]
C1552551
neuropathic pain medications prior to start of study including gabapentin, pregabalin, amytriptyline, and duloxetine (but initiation of neuropathic pain medications during treatment are permissible)
Beschrijving

Drugs used in neuropathic pain | gabapentin | pregabalin | Amitriptyline | duloxetine

Datatype

boolean

Alias
UMLS CUI [1]
C1319667
UMLS CUI [2]
C0060926
UMLS CUI [3]
C0657912
UMLS CUI [4]
C0002600
UMLS CUI [5]
C0245561
patients needing ambulatory assist devices
Beschrijving

Patient need for Walking assistive device

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C3874140
back or lower extremity surgery in the last 6 months
Beschrijving

Back surgery | Surgical procedure on lower extremity

Datatype

boolean

Alias
UMLS CUI [1]
C0741419
UMLS CUI [2]
C0187763
back or lower extremity surgery at any timepoint that interferes with gait and balance per patient or provider report
Beschrijving

Back surgery Interferes with Gait | Surgical procedure on lower extremity Interferes with Gait | Back surgery Interferes with Balance | Surgical procedure on lower extremity Interferes with Balance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0741419
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0016928
UMLS CUI [2,1]
C0187763
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0016928
UMLS CUI [3,1]
C0741419
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0014653
UMLS CUI [4,1]
C0187763
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0014653
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Similar models

Eligibility Breast Cancer NCT02125019

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | First line Adjuvant therapy | First line Neoadjuvant Therapy | Paclitaxel | docetaxel
Item
patients (men and women) diagnosed with breast cancer stages i-iii initiating first line adjuvant or neoadjuvant therapy with paclitaxel or docetaxel
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C1708063 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0144576 (UMLS CUI [4])
C0246415 (UMLS CUI [5])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Functional Limitation Due to Musculoskeletal problem
Item
patients with functional limitations due to musculoskeletal conditions can be included, because these conditions are known to remain stable over the relatively short duration of the study.
boolean
C4542603 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0026859 (UMLS CUI [1,3])
Standard Pharmaceutical Preparations | Investigational New Drugs | Standard Chemotherapeutic Agents
Item
concurrent standard and investigational agents are permissible with the standard chemotherapy drugs.
boolean
C1442989 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
C1442989 (UMLS CUI [3,1])
C0003392 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Breast Carcinoma | Targeted Therapy Breast Carcinoma | Prior Chemotherapy Cancer Other Associated with Neuropathy | Targeted Therapy Cancer Other Associated with Neuropathy | Platinum Therapy | bortezomib | Vinblastine
Item
prior known chemotherapy or targeted therapy (for breast cancer or other malignancies that is known to be associated with neuropathy in the last 12 months(platinum therapy, bortezomib, vinblastine, etc.)
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C1707251 (UMLS CUI [3,2])
C0332281 (UMLS CUI [3,3])
C0442874 (UMLS CUI [3,4])
C2985566 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C0332281 (UMLS CUI [4,3])
C0442874 (UMLS CUI [4,4])
C0032207 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1176309 (UMLS CUI [6])
C0042670 (UMLS CUI [7])
Exposure to Taxane
Item
prior taxane exposure at any time
boolean
C0332157 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
Neuropathy Type Any
Item
preexisting known diagnosis of any type of neuropathy prior to start of paclitaxel or docetaxel chemotherapy
boolean
C0442874 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Informed Consent Unable
Item
unable to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Amputation of lower limb Pre-existing
Item
preexisting lower extremity amputation
boolean
C0337308 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Difficulty walking unassisted | Lacking Able to stand alone | Etiology Condition Any
Item
inability to walk or stand without assistance due to any condition
boolean
C2183457 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C0560202 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0348080 (UMLS CUI [3,2])
C1552551 (UMLS CUI [3,3])
Drugs used in neuropathic pain | gabapentin | pregabalin | Amitriptyline | duloxetine
Item
neuropathic pain medications prior to start of study including gabapentin, pregabalin, amytriptyline, and duloxetine (but initiation of neuropathic pain medications during treatment are permissible)
boolean
C1319667 (UMLS CUI [1])
C0060926 (UMLS CUI [2])
C0657912 (UMLS CUI [3])
C0002600 (UMLS CUI [4])
C0245561 (UMLS CUI [5])
Patient need for Walking assistive device
Item
patients needing ambulatory assist devices
boolean
C0686904 (UMLS CUI [1,1])
C3874140 (UMLS CUI [1,2])
Back surgery | Surgical procedure on lower extremity
Item
back or lower extremity surgery in the last 6 months
boolean
C0741419 (UMLS CUI [1])
C0187763 (UMLS CUI [2])
Back surgery Interferes with Gait | Surgical procedure on lower extremity Interferes with Gait | Back surgery Interferes with Balance | Surgical procedure on lower extremity Interferes with Balance
Item
back or lower extremity surgery at any timepoint that interferes with gait and balance per patient or provider report
boolean
C0741419 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,3])
C0187763 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0016928 (UMLS CUI [2,3])
C0741419 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0014653 (UMLS CUI [3,3])
C0187763 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0014653 (UMLS CUI [4,3])
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