ID

26006

Description

First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00389155

Link

https://clinicaltrials.gov/show/NCT00389155

Keywords

  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 4, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Bladder Cancer NCT00389155

Eligibility Bladder Cancer NCT00389155

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic
Description

Transitional cell carcinoma of the urothelial tract Advanced Locally | Transitional cell carcinoma of the urothelial tract metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C2145472
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C2145472
UMLS CUI [2,2]
C1522484
ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:
Description

Therapeutic procedure Cisplatin Based | Patient Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0008838
UMLS CUI [1,3]
C1705938
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1512714
calculated creatinine clearance ≤60 ml/min: or
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
new york heart association classification stage iii-iv congestive heart failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
measurable disease documented by imaging with at least one uni-dimensional lesion
Description

Measurable Disease | Lesion Linear Quantity Imaging

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205132
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0011923
adequate performance status (ecog 0, 1, or 2)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
men and women ≥18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients in whom radiation or surgery is indicated
Description

Indication Therapeutic radiology procedure | Indication Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1522449
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0543467
current neuropathy ≥ ctcae grade 3
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
prior radiation to ≥ 30% of bone marrow
Description

Therapeutic radiology procedure Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
inadequate renal function: serum creatinine clearance ≤ 20 ml/min
Description

Abnormal renal function | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0373595
prior allergy to any vinca alkaloid
Description

Vinca alkaloid allergy

Data type

boolean

Alias
UMLS CUI [1]
C0570714

Similar models

Eligibility Bladder Cancer NCT00389155

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Transitional cell carcinoma of the urothelial tract Advanced Locally | Transitional cell carcinoma of the urothelial tract metastatic
Item
clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic
boolean
C2145472 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C2145472 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Therapeutic procedure Cisplatin Based | Patient Ineligible
Item
ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:
boolean
C0087111 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance ≤60 ml/min: or
boolean
C2711451 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
new york heart association classification stage iii-iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Measurable Disease | Lesion Linear Quantity Imaging
Item
measurable disease documented by imaging with at least one uni-dimensional lesion
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0011923 (UMLS CUI [2,4])
ECOG performance status
Item
adequate performance status (ecog 0, 1, or 2)
boolean
C1520224 (UMLS CUI [1])
Age
Item
men and women ≥18 years of age
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Indication Therapeutic radiology procedure | Indication Operative Surgical Procedures
Item
patients in whom radiation or surgery is indicated
boolean
C3146298 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Neuropathy CTCAE Grades
Item
current neuropathy ≥ ctcae grade 3
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Therapeutic radiology procedure Bone Marrow Percentage
Item
prior radiation to ≥ 30% of bone marrow
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Abnormal renal function | Creatinine clearance measurement
Item
inadequate renal function: serum creatinine clearance ≤ 20 ml/min
boolean
C0151746 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Vinca alkaloid allergy
Item
prior allergy to any vinca alkaloid
boolean
C0570714 (UMLS CUI [1])

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