ID

31547

Beschreibung

A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients (SUnitinib Prospective CardiovasculaR Effect); ODM derived from: https://clinicaltrials.gov/show/NCT01014065 Sponsor: AHS Cancer Control Alberta Collaborator: Cross Cancer Institute Information provided by (Responsible Party): AHS Cancer Control Alberta Principal Investigator: Mark Haykowsky, PhD University of Alberta

Link

https://clinicaltrials.gov/show/NCT01014065

Stichworte

Versionen (1)
  1. 03.09.18 03.09.18 -
Rechteinhaber

AHS Cancer Control Alberta

Hochgeladen am

3. September 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Renal Cell Carcinoma NCT01014065

Englisch

Eligibility Renal Cell Carcinoma NCT01014065

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic diagnosis of metastatic renal cell carcinoma
Beschreibung

Histological confirmation of metastatic renal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449575
UMLS CUI [1,2]
C0278678
eligible to receive first-line sunitinib
Beschreibung

Eligibility to receive first-line sunitinib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C1176020
willingness to attend cross cancer institute and university of alberta for study-related assessments
Beschreibung

Attendance at the cross cancer institute and university of alberta

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C2827364
UMLS CUI [1,3]
C0600109
karnofsky performance status (kps)82 ≥ 70
Beschreibung

Karnofsky performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
age ≥ 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate creatinine clearance to receive gadolinium
Beschreibung

Adequate creatinine clearance to receive gadolinium

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016911
UMLS CUI [1,2]
C0373595
all patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to cpet;
Beschreibung

Bone metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0153690
fluent in english language
Beschreibung

Fluency in English language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
no contraindication to mri or other concern eg., metallic implants, claustrophobia
Beschreibung

Contraindications to mri

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic therapy for mrcc
Beschreibung

Prior systemic therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0278678
documented history of major cardiac event in last year i.e. mi, unstable angina, cabg, symptomatic chf, cva or tia, or pulmonary embolism
Beschreibung

History of major cardiac event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C1275842
UMLS CUI [5]
C1275835
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C0231220
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0455536
UMLS CUI [9]
C0034065
pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate
Beschreibung

Concomitant severe medical condition or abnormality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
unstable brain metastases
Beschreibung

Brain metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0443343
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Ähnliche Modelle

Eligibility Renal Cell Carcinoma NCT01014065

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Histological confirmation of metastatic renal cell carcinoma
Item
histologic diagnosis of metastatic renal cell carcinoma
boolean
C0449575 (UMLS CUI [1,1])
C0278678 (UMLS CUI [1,2])
Eligibility to receive first-line sunitinib
Item
eligible to receive first-line sunitinib
boolean
C1548635 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C1176020 (UMLS CUI [1,3])
Attendance at the cross cancer institute and university of alberta
Item
willingness to attend cross cancer institute and university of alberta for study-related assessments
boolean
C2825164 (UMLS CUI [1,1])
C2827364 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Karnofsky performance status
Item
karnofsky performance status (kps)82 ≥ 70
boolean
C0206065 (UMLS CUI [1])
Age
Item
age ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Adequate creatinine clearance to receive gadolinium
Item
adequate creatinine clearance to receive gadolinium
boolean
C0016911 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
Bone metastases
Item
all patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to cpet;
boolean
C0153690 (UMLS CUI [1])
Fluency in English language
Item
fluent in english language
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Contraindications to mri
Item
no contraindication to mri or other concern eg., metallic implants, claustrophobia
boolean
C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior systemic therapy
Item
prior systemic therapy for mrcc
boolean
C1515119 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0278678 (UMLS CUI [1,3])
History of major cardiac event
Item
documented history of major cardiac event in last year i.e. mi, unstable angina, cabg, symptomatic chf, cva or tia, or pulmonary embolism
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C1275842 (UMLS CUI [4])
C1275835 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C0038454 (UMLS CUI [7])
C0455536 (UMLS CUI [8])
C0034065 (UMLS CUI [9])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Concomitant severe medical condition or abnormality
Item
other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Brain metastasis
Item
unstable brain metastases
boolean
C0686377 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
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