ID

18132

Beschreibung

MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00606866

Link

https://clinicaltrials.gov/show/NCT00606866

Stichworte

Versionen (1)
  1. 21.10.16 21.10.16 -
Hochgeladen am

21. Oktober 2016

DOI

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Creative Commons BY 4.0
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Eligibility Metastatic Renal Cell Carcinoma NCT00606866

Englisch

Eligibility Metastatic Renal Cell Carcinoma NCT00606866

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic clear cell renal cell cancer;
Beschreibung

Clear Cell Renal Cell Carcinoma Metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C0036525
at least one lesion that can be accurately measured in at least one dimension;
Beschreibung

Measurable Disease Linear Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
patients must not have been treated with prior anti-timor kinase inhibitors or vegf pathway inhibitors;
Beschreibung

Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1152564
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C2984329
UMLS CUI [2,2]
C0243077
age 18 and older;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-2;
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
Beschreibung

Blood pressure finding Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1271104
UMLS CUI [1,2]
C1265611
normal organ function: total bilirubin less than upper limit of normal, ast less than 2.5 x upper limit of normal, creatinine less than 2.8 mg/dl;
Beschreibung

organ function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201976
women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
Beschreibung

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
ability to understand and the willingness to sign a written informed consent document.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy or radiotherapy within 4 weeks prior to entering the study;
Beschreibung

Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
any other investigational agents;
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
known brain metastases;
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
Beschreibung

Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C1321605
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C1321605
UMLS CUI [7,3]
C0439801
pregnancy.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
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Ähnliche Modelle

Eligibility Metastatic Renal Cell Carcinoma NCT00606866

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Clear Cell Renal Cell Carcinoma Metastatic
Item
histologically or cytologically confirmed metastatic clear cell renal cell cancer;
boolean
C0279702 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Measurable Disease Linear Quantity
Item
at least one lesion that can be accurately measured in at least one dimension;
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors
Item
patients must not have been treated with prior anti-timor kinase inhibitors or vegf pathway inhibitors;
boolean
C1152564 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2984329 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
Age
Item
age 18 and older;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2;
boolean
C1520224 (UMLS CUI [1])
Blood pressure finding Quantity
Item
blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
boolean
C1271104 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
organ function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
normal organ function: total bilirubin less than upper limit of normal, ast less than 2.5 x upper limit of normal, creatinine less than 2.8 mg/dl;
boolean
C0678852 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
chemotherapy or radiotherapy within 4 weeks prior to entering the study;
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Investigational New Drugs
Item
any other investigational agents;
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastases;
boolean
C0220650 (UMLS CUI [1])
Illness Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | social situation Compliance behavior Limited
Item
uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C1321605 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C1321605 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
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