ID

31805

Beskrivning

VEGF Imaging in Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00831857

Länk

https://clinicaltrials.gov/show/NCT00831857

Nyckelord

Versioner (1)
  1. 2018-09-29 2018-09-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT00831857

Engelsk

Eligibility Renal Cell Carcinoma NCT00831857

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced irresectable or metastatic renal cell cancer
Beskrivning

Renal Cell Carcinoma Advanced Locally unresectable | Metastatic Renal Cell Cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C1519810
UMLS CUI [2]
C0278678
no untreated brain metastases (ct or mri not necessary in the absence of symptoms)
Beskrivning

Metastatic malignant neoplasm to brain Untreated Absent | Symptoms Absent | CT Redundant | MRI Redundant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0040405
UMLS CUI [3,2]
C1313915
UMLS CUI [4,1]
C0024485
UMLS CUI [4,2]
C1313915
no uncontrolled hypertension
Beskrivning

Uncontrolled hypertension Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0332197
no clinically significant cardiovascular events or disease during the last 12 months
Beskrivning

Cardiovascular event Absent | Cardiovascular Disease Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0332197
no surgery in the last 4 weeks
Beskrivning

Operative Surgical Procedures Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332197
no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months
Beskrivning

Bevacizumab Absent | Monoclonal Antibodies Absent | Angiogenesis Inhibitors Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0796392
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0003250
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0596087
UMLS CUI [3,2]
C0332197
no treatment with a tyrosine kinase inhibitor during the last 4 weeks
Beskrivning

Tyrosine kinase inhibitor Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1268567
UMLS CUI [1,2]
C0332197
measurable disease with x-ray or ct scan, at least one site of disease must be unidimensionally measurable as follows: x-ray > 20 mm, spiral ct scan > 10 mm, non-spiral ct scan > 20 mm
Beskrivning

Measurable Disease X-Ray | Measurable Disease CT scan | Site Measurable Linear X-Ray | Site Measurable Linear Spiral CT scan | Site Measurable Linear CT scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0034571
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C1513040
UMLS CUI [3,3]
C0205132
UMLS CUI [3,4]
C0034571
UMLS CUI [4,1]
C1515974
UMLS CUI [4,2]
C1513040
UMLS CUI [4,3]
C0205132
UMLS CUI [4,4]
C0860888
UMLS CUI [5,1]
C1515974
UMLS CUI [5,2]
C1513040
UMLS CUI [5,3]
C0205132
UMLS CUI [5,4]
C0040405
clear cell histology component
Beskrivning

Clear cell renal cell carcinoma Component

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C1705248
not pregnant or nursing
Beskrivning

Pregnancy Absent | Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
women of childbearing potential must use effective contraception
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Beskrivning

Exclusion Criteria | Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0241888
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C3850138
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0017444
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
before patient randomization, written informed consent must be given according to gcp, and local regulations
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Renal Cell Carcinoma NCT00831857

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Renal Cell Carcinoma Advanced Locally unresectable | Metastatic Renal Cell Cancer
Item
locally advanced irresectable or metastatic renal cell cancer
boolean
C0007134 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1519810 (UMLS CUI [1,4])
C0278678 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Untreated Absent | Symptoms Absent | CT Redundant | MRI Redundant
Item
no untreated brain metastases (ct or mri not necessary in the absence of symptoms)
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0040405 (UMLS CUI [3,1])
C1313915 (UMLS CUI [3,2])
C0024485 (UMLS CUI [4,1])
C1313915 (UMLS CUI [4,2])
Uncontrolled hypertension Absent
Item
no uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Cardiovascular event Absent | Cardiovascular Disease Absent
Item
no clinically significant cardiovascular events or disease during the last 12 months
boolean
C1320716 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Operative Surgical Procedures Absent
Item
no surgery in the last 4 weeks
boolean
C0543467 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Bevacizumab Absent | Monoclonal Antibodies Absent | Angiogenesis Inhibitors Absent
Item
no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months
boolean
C0796392 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003250 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0596087 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Tyrosine kinase inhibitor Absent
Item
no treatment with a tyrosine kinase inhibitor during the last 4 weeks
boolean
C1268567 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable Disease X-Ray | Measurable Disease CT scan | Site Measurable Linear X-Ray | Site Measurable Linear Spiral CT scan | Site Measurable Linear CT scan
Item
measurable disease with x-ray or ct scan, at least one site of disease must be unidimensionally measurable as follows: x-ray > 20 mm, spiral ct scan > 10 mm, non-spiral ct scan > 20 mm
boolean
C1513041 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0205132 (UMLS CUI [3,3])
C0034571 (UMLS CUI [3,4])
C1515974 (UMLS CUI [4,1])
C1513040 (UMLS CUI [4,2])
C0205132 (UMLS CUI [4,3])
C0860888 (UMLS CUI [4,4])
C1515974 (UMLS CUI [5,1])
C1513040 (UMLS CUI [5,2])
C0205132 (UMLS CUI [5,3])
C0040405 (UMLS CUI [5,4])
Clear cell renal cell carcinoma Component
Item
clear cell histology component
boolean
C0279702 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must use effective contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria | Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
Item
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
boolean
C0680251 (UMLS CUI [1])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0241888 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C3850138 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0017444 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Informed Consent
Item
before patient randomization, written informed consent must be given according to gcp, and local regulations
boolean
C0021430 (UMLS CUI [1])
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