ID

16532

Beschrijving

A Research Study for Patients With Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00106613

Link

https://clinicaltrials.gov/show/NCT00106613

Trefwoorden

  1. 22-07-16 22-07-16 -
Geüploaded op

22 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Carcinoma, Renal Cell NCT00106613

Eligibility Carcinoma, Renal Cell NCT00106613

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must fulfill all of the following criteria to be eligible for study participation:
Beschrijving

criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
age ≥ 18 years;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed renal cell carcinoma (rcc);
Beschrijving

Renal Cell Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007134
metastatic disease, with measurable lesions according to the response evaluation criteria in solid tumors (recist);
Beschrijving

Metastatic Neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C2939420
failure of prior cytokine therapy;
Beschrijving

Cytokine therapy failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0199974
UMLS CUI [1,2]
C0231175
documented progressive disease;
Beschrijving

Progressive Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1335499
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients are ineligible for entry if any of the following criteria are met:
Beschrijving

criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
Beschrijving

Heart Disease Significant | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled | Angina control - poor

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0421196
history of serious ventricular arrhythmia
Beschrijving

Ventricular arrhythmia Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C0205404
corrected qt interval (qtc) ≥ 500 msec
Beschrijving

QTc

Datatype

boolean

Alias
UMLS CUI [1]
C0860814
known infection with human immunodeficiency virus (hiv), hepatitis b, or hepatitis c;
Beschrijving

HIV Infection | Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
previous extensive radiotherapy involving ≥ 30% of bone marrow
Beschrijving

prior radiation therapy Extensive Involving Bone Marrow

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205231
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0005953
coexistent second malignancy or history of prior malignancy within previous 5 years
Beschrijving

Neoplasm, Second Primary | H/O: malignant neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0455471

Similar models

Eligibility Carcinoma, Renal Cell NCT00106613

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
criteria Fulfill
Item
patients must fulfill all of the following criteria to be eligible for study participation:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
age ≥ 18 years;
boolean
C0001779 (UMLS CUI [1])
Renal Cell Carcinoma
Item
histologically confirmed renal cell carcinoma (rcc);
boolean
C0007134 (UMLS CUI [1])
Metastatic Neoplasm
Item
metastatic disease, with measurable lesions according to the response evaluation criteria in solid tumors (recist);
boolean
C2939420 (UMLS CUI [1])
Cytokine therapy failed
Item
failure of prior cytokine therapy;
boolean
C0199974 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Progressive Disease
Item
documented progressive disease;
boolean
C1335499 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
criteria Fulfill
Item
patients are ineligible for entry if any of the following criteria are met:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Heart Disease Significant | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled | Angina control - poor
Item
significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0421196 (UMLS CUI [5])
Ventricular arrhythmia Serious
Item
history of serious ventricular arrhythmia
boolean
C0085612 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
QTc
Item
corrected qt interval (qtc) ≥ 500 msec
boolean
C0860814 (UMLS CUI [1])
HIV Infection | Hepatitis B | Hepatitis C
Item
known infection with human immunodeficiency virus (hiv), hepatitis b, or hepatitis c;
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
prior radiation therapy Extensive Involving Bone Marrow
Item
previous extensive radiotherapy involving ≥ 30% of bone marrow
boolean
C0279134 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0005953 (UMLS CUI [1,4])
Neoplasm, Second Primary | H/O: malignant neoplasm
Item
coexistent second malignancy or history of prior malignancy within previous 5 years
boolean
C0085183 (UMLS CUI [1])
C0455471 (UMLS CUI [2])

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