ID

22695

Beschreibung

Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT00672594

Link

https://clinicaltrials.gov/show/NCT00672594

Stichworte

Versionen (1)
  1. 09.06.17 09.06.17 -
Hochgeladen am

9. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00672594

Englisch

Eligibility Prostate Cancer NCT00672594

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic evidence of adenocarcinoma of the prostate deemed candidates for curative rrp
Beschreibung

Adenocarcinoma of prostate | Indication Radical retropubic prostatectomy Curative

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0194825
UMLS CUI [2,3]
C1276305
intermediate or high risk, clinically localized disease
Beschreibung

Local disease Intermediate Risk | Local disease High risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277565
UMLS CUI [1,2]
C3640764
UMLS CUI [2,1]
C0277565
UMLS CUI [2,2]
C0332167
adequate organ function
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
patients must be surgically sterile or must agree to use effective contraception during the period of therapy
Beschreibung

Male sterilization | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0024559
UMLS CUI [2]
C0700589
select imaging to rule out metastasis will be done as clinically indicated
Beschreibung

Indication Imaging | Neoplasm Metastasis Exclude

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C2828389
signed and date informed consent document
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment for prostate cancer
Beschreibung

Therapeutic procedure Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
major surgery or radiation therapy within 4 weeks of starting the study treatment
Beschreibung

Major surgery | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C1522449
nci ctcae grade 3 hemorrhage within 4 weeks of starting therapy
Beschreibung

Hemorrhage CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1516728
history of or known metastatic prostate cancer
Beschreibung

Metastatic Prostate Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0936223
any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
Beschreibung

Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C3495795
UMLS CUI [6]
C0742758
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0007787
UMLS CUI [9]
C0034065
ongoing cardiac dysrhythmias of nci ctcae grade 2 or greater
Beschreibung

Cardiac Arrhythmia CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1516728
qtc interval > 500 msec on baseline ekg
Beschreibung

Prolonged QTc interval on electrocardiogram (ECG)

Datentyp

boolean

Alias
UMLS CUI [1]
C4015677
hypertension that cannot be controlled by medications (>150/100 mm hg despite optimal medical therapy).
Beschreibung

Uncontrolled hypertension | Therapeutic procedure Optimal

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2698651
pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
Beschreibung

Thyroid Disease Pre-existing | Thyroid function decreased | Pharmaceutical Preparations failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0858730
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0231175
known active infection
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
concurrent treatment on another clinical trial. supportive care trials or non-treatment trials, e.g. qol, are allowed.
Beschreibung

Study Subject Participation Status | Therapeutic procedure | Supportive care | Quality of life

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0344211
UMLS CUI [4]
C0034380
other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Beschreibung

Medical condition Severe | Mental disorder Severe | Laboratory test result abnormal | Study Subject Participation Status Risk Increase | Investigational New Drugs Risk Increase | Medical condition Interferes with Interpretation Research results | Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0438215
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C0035647
UMLS CUI [4,3]
C0442805
UMLS CUI [5,1]
C0013230
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C0442805
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C2348568
UMLS CUI [7,2]
C1548788
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00672594

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Indication Radical retropubic prostatectomy Curative
Item
histologic evidence of adenocarcinoma of the prostate deemed candidates for curative rrp
boolean
C0007112 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0194825 (UMLS CUI [2,2])
C1276305 (UMLS CUI [2,3])
Local disease Intermediate Risk | Local disease High risk
Item
intermediate or high risk, clinically localized disease
boolean
C0277565 (UMLS CUI [1,1])
C3640764 (UMLS CUI [1,2])
C0277565 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Male sterilization | Contraceptive methods
Item
patients must be surgically sterile or must agree to use effective contraception during the period of therapy
boolean
C0024559 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Indication Imaging | Neoplasm Metastasis Exclude
Item
select imaging to rule out metastasis will be done as clinically indicated
boolean
C3146298 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Informed Consent
Item
signed and date informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Prostate carcinoma
Item
prior treatment for prostate cancer
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Major surgery | Therapeutic radiology procedure
Item
major surgery or radiation therapy within 4 weeks of starting the study treatment
boolean
C0679637 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Hemorrhage CTCAE Grades
Item
nci ctcae grade 3 hemorrhage within 4 weeks of starting therapy
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic Prostate Carcinoma
Item
history of or known metastatic prostate cancer
boolean
C0936223 (UMLS CUI [1])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral artery bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism
Item
any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C3495795 (UMLS CUI [5])
C0742758 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
C0034065 (UMLS CUI [9])
Cardiac Arrhythmia CTCAE Grades
Item
ongoing cardiac dysrhythmias of nci ctcae grade 2 or greater
boolean
C0003811 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Prolonged QTc interval on electrocardiogram (ECG)
Item
qtc interval > 500 msec on baseline ekg
boolean
C4015677 (UMLS CUI [1])
Uncontrolled hypertension | Therapeutic procedure Optimal
Item
hypertension that cannot be controlled by medications (>150/100 mm hg despite optimal medical therapy).
boolean
C1868885 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
Thyroid Disease Pre-existing | Thyroid function decreased | Pharmaceutical Preparations failed
Item
pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
boolean
C0040128 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0858730 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
Communicable Disease
Item
known active infection
boolean
C0009450 (UMLS CUI [1])
Study Subject Participation Status | Therapeutic procedure | Supportive care | Quality of life
Item
concurrent treatment on another clinical trial. supportive care trials or non-treatment trials, e.g. qol, are allowed.
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0344211 (UMLS CUI [3])
C0034380 (UMLS CUI [4])
Medical condition Severe | Mental disorder Severe | Laboratory test result abnormal | Study Subject Participation Status Risk Increase | Investigational New Drugs Risk Increase | Medical condition Interferes with Interpretation Research results | Study Subject Participation Status Inappropriate
Item
other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0438215 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0442805 (UMLS CUI [4,3])
C0013230 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0442805 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C2348568 (UMLS CUI [7,1])
C1548788 (UMLS CUI [7,2])
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