ID

18132

Description

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

Lien

https://clinicaltrials.gov/show/NCT00606866

Mots-clés

  1. 21/10/2016 21/10/2016 -
Téléchargé le

21 octobre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Metastatic Renal Cell Carcinoma NCT00606866

Eligibility Metastatic Renal Cell Carcinoma NCT00606866

Inclusion Criteria
Description

Inclusion Criteria

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

Clear Cell Renal Cell Carcinoma Metastatic

Type de données

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;
Description

Measurable Disease Linear Quantity

Type de données

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;
Description

Kinase Inhibitors Against Malignant Neoplasms | VEGF Signaling Pathway inhibitors

Type de données

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;
Description

Age

Type de données

boolean

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

ECOG performance status

Type de données

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;
Description

Blood pressure finding Quantity

Type de données

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;
Description

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

Type de données

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;
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Type de données

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.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Chemotherapy | Therapeutic radiology procedure

Type de données

boolean

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

Investigational New Drugs

Type de données

boolean

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

Metastatic malignant neoplasm to brain

Type de données

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;
Description

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

Type de données

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.
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Metastatic Renal Cell Carcinoma NCT00606866

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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