ID

31565

Beschrijving

Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT); ODM derived from: https://clinicaltrials.gov/show/NCT00635167

Link

https://clinicaltrials.gov/show/NCT00635167

Trefwoorden

Versies (1)
  1. 04-09-18 04-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 september 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00635167

Engels

Eligibility Prostate Cancer NCT00635167

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men aged 40 - 80 years old
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a gleason score of 7 or higher, clinical stage t2b or higher, or psa > 10. pathology will be confirmed by at least two reviews
Beschrijving

Prostate carcinoma Localized Intermediate Risk Gleason score | Prostate carcinoma Localized High risk Gleason score | Prostate carcinoma Localized Intermediate Risk TNM clinical staging | Prostate carcinoma Localized High risk TNM clinical staging | Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0392752
UMLS CUI [1,3]
C3640764
UMLS CUI [1,4]
C3203027
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C0392752
UMLS CUI [2,3]
C4319571
UMLS CUI [2,4]
C3203027
UMLS CUI [3,1]
C0600139
UMLS CUI [3,2]
C0392752
UMLS CUI [3,3]
C3640764
UMLS CUI [3,4]
C3258246
UMLS CUI [4,1]
C0600139
UMLS CUI [4,2]
C0392752
UMLS CUI [4,3]
C4319571
UMLS CUI [4,4]
C3258246
UMLS CUI [5]
C0201544
patients opting for ebrt (external beam radiation therapy, standard of care) without hormonal ablation
Beschrijving

Option External beam radiotherapy | Ablation Hormonal Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518601
UMLS CUI [1,2]
C0419095
UMLS CUI [2,1]
C0547070
UMLS CUI [2,2]
C0458083
UMLS CUI [2,3]
C0332197
ability to undergo serial trus procedures
Beschrijving

Ability Receive TRUS

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C2960324
ability to give informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has known hypersensitivity to octafluoropropane.
Beschrijving

Hypersensitivity Perflutren

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0937858
evidence of distant metastatic disease on staging evaluation
Beschrijving

Distant metastasis TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C3258246
previous treatment for prostate cancer, including any form of androgen ablation
Beschrijving

Prior Therapy Prostate carcinoma | Androgen suppression

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C1515985
previous procedures involving the anus or rectum, making serial trus difficult or dangerous
Beschrijving

Procedures on Anus | Procedures on Rectum | TRUS Difficult

Datatype

boolean

Alias
UMLS CUI [1]
C0870072
UMLS CUI [2]
C0869814
UMLS CUI [3,1]
C2960324
UMLS CUI [3,2]
C0332218
expected life expectancy less than 10 years
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
baseline testosterone < 200 ng/dl
Beschrijving

Testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0523912
subject with cardiac shunts and elevated pulmonary hypertension
Beschrijving

Cardiac shunt | Pulmonary Hypertension Elevated

Datatype

boolean

Alias
UMLS CUI [1]
C0232180
UMLS CUI [2,1]
C0020542
UMLS CUI [2,2]
C3163633
subject has worsening or clinically unstable congestive heart failure.
Beschrijving

Congestive heart failure Worsening | Congestive heart failure Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0332271
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0443343
subject has acute myocardial infarction or acute coronary syndrome.
Beschrijving

Myocardial Infarction | Acute Coronary Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0948089
subject has ventricular arrhythmias or is high risk for arrhythmias.
Beschrijving

Ventricular arrhythmia | High risk of Cardiac Arrhythmia

Datatype

boolean

Alias
UMLS CUI [1]
C0085612
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0003811
subject has respiratory failure, severe emphysema or pulmonary emboli.
Beschrijving

Respiratory Failure | Emphysema Severe | Pulmonary Embolism

Datatype

boolean

Alias
UMLS CUI [1]
C1145670
UMLS CUI [2,1]
C0034067
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0034065
subject has a history of cardiac shunt or pulmonary hypertension.
Beschrijving

Medical History Cardiac shunt | Medical History Pulmonary Hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0232180
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0020542
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Similar models

Eligibility Prostate Cancer NCT00635167

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men aged 40 - 80 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Prostate carcinoma Localized Intermediate Risk Gleason score | Prostate carcinoma Localized High risk Gleason score | Prostate carcinoma Localized Intermediate Risk TNM clinical staging | Prostate carcinoma Localized High risk TNM clinical staging | Prostate specific antigen measurement
Item
biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a gleason score of 7 or higher, clinical stage t2b or higher, or psa > 10. pathology will be confirmed by at least two reviews
boolean
C0600139 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C3640764 (UMLS CUI [1,3])
C3203027 (UMLS CUI [1,4])
C0600139 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C4319571 (UMLS CUI [2,3])
C3203027 (UMLS CUI [2,4])
C0600139 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
C3640764 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
C0600139 (UMLS CUI [4,1])
C0392752 (UMLS CUI [4,2])
C4319571 (UMLS CUI [4,3])
C3258246 (UMLS CUI [4,4])
C0201544 (UMLS CUI [5])
Option External beam radiotherapy | Ablation Hormonal Absent
Item
patients opting for ebrt (external beam radiation therapy, standard of care) without hormonal ablation
boolean
C1518601 (UMLS CUI [1,1])
C0419095 (UMLS CUI [1,2])
C0547070 (UMLS CUI [2,1])
C0458083 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Ability Receive TRUS
Item
ability to undergo serial trus procedures
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C2960324 (UMLS CUI [1,3])
Informed Consent
Item
ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Perflutren
Item
subject has known hypersensitivity to octafluoropropane.
boolean
C0020517 (UMLS CUI [1,1])
C0937858 (UMLS CUI [1,2])
Distant metastasis TNM clinical staging
Item
evidence of distant metastatic disease on staging evaluation
boolean
C1269798 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prior Therapy Prostate carcinoma | Androgen suppression
Item
previous treatment for prostate cancer, including any form of androgen ablation
boolean
C1514463 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1515985 (UMLS CUI [2])
Procedures on Anus | Procedures on Rectum | TRUS Difficult
Item
previous procedures involving the anus or rectum, making serial trus difficult or dangerous
boolean
C0870072 (UMLS CUI [1])
C0869814 (UMLS CUI [2])
C2960324 (UMLS CUI [3,1])
C0332218 (UMLS CUI [3,2])
Life Expectancy
Item
expected life expectancy less than 10 years
boolean
C0023671 (UMLS CUI [1])
Testosterone measurement
Item
baseline testosterone < 200 ng/dl
boolean
C0523912 (UMLS CUI [1])
Cardiac shunt | Pulmonary Hypertension Elevated
Item
subject with cardiac shunts and elevated pulmonary hypertension
boolean
C0232180 (UMLS CUI [1])
C0020542 (UMLS CUI [2,1])
C3163633 (UMLS CUI [2,2])
Congestive heart failure Worsening | Congestive heart failure Unstable
Item
subject has worsening or clinically unstable congestive heart failure.
boolean
C0018802 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Myocardial Infarction | Acute Coronary Syndrome
Item
subject has acute myocardial infarction or acute coronary syndrome.
boolean
C0027051 (UMLS CUI [1])
C0948089 (UMLS CUI [2])
Ventricular arrhythmia | High risk of Cardiac Arrhythmia
Item
subject has ventricular arrhythmias or is high risk for arrhythmias.
boolean
C0085612 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0003811 (UMLS CUI [2,2])
Respiratory Failure | Emphysema Severe | Pulmonary Embolism
Item
subject has respiratory failure, severe emphysema or pulmonary emboli.
boolean
C1145670 (UMLS CUI [1])
C0034067 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0034065 (UMLS CUI [3])
Medical History Cardiac shunt | Medical History Pulmonary Hypertension
Item
subject has a history of cardiac shunt or pulmonary hypertension.
boolean
C0262926 (UMLS CUI [1,1])
C0232180 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0020542 (UMLS CUI [2,2])
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