ID

38192

Descrição

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

Palavras-chave

Versões (1)
  1. 25/09/2019 25/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

25 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02125019

Inglês

Eligibility Breast Cancer NCT02125019

1 Formulários  
Inclusion Criteria
Descrição

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
Descrição

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

Tipo de dados

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.
Descrição

Informed Consent

Tipo de dados

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.
Descrição

Functional Limitation Due to Musculoskeletal problem

Tipo de dados

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.
Descrição

Standard Pharmaceutical Preparations | Investigational New Drugs | Standard Chemotherapeutic Agents

Tipo de dados

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
Descrição

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.)
Descrição

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

Tipo de dados

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
Descrição

Exposure to Taxane

Tipo de dados

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
Descrição

Neuropathy Type Any

Tipo de dados

boolean

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

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Informed Consent Unable

Tipo de dados

boolean

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

Amputation of lower limb Pre-existing

Tipo de dados

boolean

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

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

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Patient need for Walking assistive device

Tipo de dados

boolean

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

Back surgery | Surgical procedure on lower extremity

Tipo de dados

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
Descrição

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

Tipo de dados

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 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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