ID

20223

Descripción

Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan; ODM derived from: https://clinicaltrials.gov/show/NCT00507143

Link

https://clinicaltrials.gov/show/NCT00507143

Palabras clave

Versiones (1)
  1. 14/2/17 14/2/17 -
Subido en

14 de febrero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00507143

Inglés

Eligibility Colorectal Neoplasms NCT00507143

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically diagnosed unresectable or metastatic colorectal cancer
Descripción

Colorectal Carcinoma unresectable | Colorectal cancer metastatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C1519810
UMLS CUI [2]
C0948380
performance status of 0, 1 and 2 on the ecog criteria
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
disease status must be that of measurable disease as defined by recist criteria (for genotype-pd study only) only non-target lesions are allowed for pk study
Descripción

Measurable Disease | Non-Target Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C2986547
no previous chemotherapy, radiotherapy on the target lesion, immunotherapy; adjuvant chemotherapy with fluoropyrimidines completed at least 6 months ago is allowed (for genotype-pd study only) previously treated patients are allowed for pk study
Descripción

Chemotherapy | Therapeutic radiology procedure Target Lesion | Immunotherapy | Adjuvant Chemotherapy Completed | fluoropyrimidine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C2986546
UMLS CUI [3]
C0021083
UMLS CUI [4,1]
C0085533
UMLS CUI [4,2]
C0205197
UMLS CUI [5]
C0596581
life expectancy of more than 3 months (for genotype-pd study only)
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
adequate major organ functions
Descripción

Organ function Major

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205164
compliant patient who can be followed-up adequately
Descripción

Compliance behavior | Follow-up Adequate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0205411
informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
active or uncontrolled infection
Descripción

Communicable Disease | Communicable Disease Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
pregnant or breast-feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with systemic disease, especially cardiovascular disease, who cannot tolerate systemic chemotherapy
Descripción

Systemic disease | Cardiovascular Disease | Patient intolerant Systemic Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0007222
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0231200
UMLS CUI [3,3]
C1883256
patients with brain metastasis (for genotype-pd study only)
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
patients treated with radiotherapy within 2 weeks (for genotype-pd study only)
Descripción

Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
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Similar models

Eligibility Colorectal Neoplasms NCT00507143

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma unresectable | Colorectal cancer metastatic
Item
histologically or cytologically diagnosed unresectable or metastatic colorectal cancer
boolean
C0009402 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0948380 (UMLS CUI [2])
ECOG performance status
Item
performance status of 0, 1 and 2 on the ecog criteria
boolean
C1520224 (UMLS CUI [1])
Measurable Disease | Non-Target Lesion
Item
disease status must be that of measurable disease as defined by recist criteria (for genotype-pd study only) only non-target lesions are allowed for pk study
boolean
C1513041 (UMLS CUI [1])
C2986547 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure Target Lesion | Immunotherapy | Adjuvant Chemotherapy Completed | fluoropyrimidine
Item
no previous chemotherapy, radiotherapy on the target lesion, immunotherapy; adjuvant chemotherapy with fluoropyrimidines completed at least 6 months ago is allowed (for genotype-pd study only) previously treated patients are allowed for pk study
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C2986546 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3])
C0085533 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0596581 (UMLS CUI [5])
Life Expectancy
Item
life expectancy of more than 3 months (for genotype-pd study only)
boolean
C0023671 (UMLS CUI [1])
Organ function Major
Item
adequate major organ functions
boolean
C0678852 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Compliance behavior | Follow-up Adequate
Item
compliant patient who can be followed-up adequately
boolean
C1321605 (UMLS CUI [1])
C3274571 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease | Communicable Disease Uncontrolled
Item
active or uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease | Cardiovascular Disease | Patient intolerant Systemic Chemotherapy
Item
patients with systemic disease, especially cardiovascular disease, who cannot tolerate systemic chemotherapy
boolean
C0442893 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C0231200 (UMLS CUI [3,2])
C1883256 (UMLS CUI [3,3])
Metastatic malignant neoplasm to brain
Item
patients with brain metastasis (for genotype-pd study only)
boolean
C0220650 (UMLS CUI [1])
Therapeutic radiology procedure
Item
patients treated with radiotherapy within 2 weeks (for genotype-pd study only)
boolean
C1522449 (UMLS CUI [1])
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