ID

28243

Beschrijving

Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00873275

Link

https://clinicaltrials.gov/show/NCT00873275

Trefwoorden

  1. 29-12-17 29-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 december 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT00873275

Eligibility Colorectal Cancer NCT00873275

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with advanced, biopsy proven metastatic colorectal cancer
Beschrijving

Colorectal cancer metastatic Advanced

Datatype

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C0205179
karnofsky performance status >= 80
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects
Beschrijving

Prior Therapy Completed | Side effects Patient recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C1115804
serum albumin and prealbumin within normal limits
Beschrijving

Serum albumin normal | Serum prealbumin Normal

Datatype

boolean

Alias
UMLS CUI [1]
C0580492
UMLS CUI [2,1]
C0518013
UMLS CUI [2,2]
C0205307
alanine aminotransferase (alt) within 3 x upper limit of normal
Beschrijving

Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
alkaline phosphatase within 3 x upper limit of normal
Beschrijving

Alkaline phosphatase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
serum bilirubin within normal limits
Beschrijving

Serum bilirubin normal

Datatype

boolean

Alias
UMLS CUI [1]
C0428443
absolute neutrophil count >= 1500/ul
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
serum creatinine within 1.5 x upper limit of normal
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
ability to understand and sign an institutional review board (irb) approved informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
ability to use appropriate contraception and no evidence of pregnancy in female patients of reproductive potential
Beschrijving

Contraceptive methods | Childbearing Potential Pregnancy Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant medical or psychiatric condition that would make treatment unsafe
Beschrijving

Medical condition Therapeutic procedure At risk | Mental disorders Therapeutic procedure At risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1444641
use of systemic steroids use within 7 days from start of trial
Beschrijving

Systemic steroids

Datatype

boolean

Alias
UMLS CUI [1]
C2825233
nursing women
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
patients unable to comply with protocol related studies and follow up
Beschrijving

Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
weight loss of greater than 10% in the last 6 months
Beschrijving

Weight decreased Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165

Similar models

Eligibility Colorectal Cancer NCT00873275

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal cancer metastatic Advanced
Item
patients with advanced, biopsy proven metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
karnofsky performance status >= 80
boolean
C0206065 (UMLS CUI [1])
Prior Therapy Completed | Side effects Patient recovered
Item
prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0879626 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Serum albumin normal | Serum prealbumin Normal
Item
serum albumin and prealbumin within normal limits
boolean
C0580492 (UMLS CUI [1])
C0518013 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Alanine aminotransferase measurement
Item
alanine aminotransferase (alt) within 3 x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase within 3 x upper limit of normal
boolean
C0201850 (UMLS CUI [1])
Serum bilirubin normal
Item
serum bilirubin within normal limits
boolean
C0428443 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count >= 1500/ul
boolean
C0948762 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine within 1.5 x upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
ability to understand and sign an institutional review board (irb) approved informed consent
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods | Childbearing Potential Pregnancy Absent
Item
ability to use appropriate contraception and no evidence of pregnancy in female patients of reproductive potential
boolean
C0700589 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical condition Therapeutic procedure At risk | Mental disorders Therapeutic procedure At risk
Item
significant medical or psychiatric condition that would make treatment unsafe
boolean
C3843040 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Systemic steroids
Item
use of systemic steroids use within 7 days from start of trial
boolean
C2825233 (UMLS CUI [1])
Breast Feeding
Item
nursing women
boolean
C0006147 (UMLS CUI [1])
Protocol Compliance Unable
Item
patients unable to comply with protocol related studies and follow up
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Weight decreased Percentage
Item
weight loss of greater than 10% in the last 6 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])

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