ID

36883

Beschrijving

Single Fraction Real-time High-Dose-Rate Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02342054

Link

https://clinicaltrials.gov/show/NCT02342054

Trefwoorden

Versies (1)
  1. 18-06-19 18-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02342054

Engels

Eligibility Prostate Cancer NCT02342054

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men older than 18 years old
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically confirmed diagnosis of adenocarcinoma of the prostate
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
clinical stage t1c/t2a disease
Beschrijving

Disease TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
low and intermediate risk disease defined as either gleason 6 or gleason 7 and psa < 20 ng/ml.
Beschrijving

Disease Low Risk | Disease Intermediate Risk | Gleason score | Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3538919
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3640764
UMLS CUI [3]
C3203027
UMLS CUI [4]
C0201544
prostate volume < 60 cc as determined by ultrasound, ct or mri
Beschrijving

Prostate volume Ultrasonography | Prostate volume CT | Prostate volume MRI

Datatype

boolean

Alias
UMLS CUI [1,1]
C1441416
UMLS CUI [1,2]
C0041618
UMLS CUI [2,1]
C1441416
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C1441416
UMLS CUI [3,2]
C0024485
life expectancy of more than 10 years
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
willing to give informed consent to participate in this clinical trial
Beschrijving

Informed Consent Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
able and willing to complete expanded prostate index composite (epic) questionnaire
Beschrijving

Expanded Prostate Cancer Index Composite Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C3810535
UMLS CUI [1,2]
C0205197
eastern cooperative oncology group (ecog) of 0 - 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
give competent informed consent to participate in this trial.
Beschrijving

Informed Consent Competent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0086035
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented nodal or distant metastases
Beschrijving

Secondary malignant neoplasm of lymph node | Distant metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0686619
UMLS CUI [2]
C1269798
previous pelvic radiotherapy
Beschrijving

Radiotherapy to pelvis

Datatype

boolean

Alias
UMLS CUI [1]
C1536155
previous trans-urethral resection of prostate, previous prostatectomy or hifu
Beschrijving

Transurethral Resection of Prostate | Prostatectomy | High-Intensity Focused Ultrasound Ablation

Datatype

boolean

Alias
UMLS CUI [1]
C0040771
UMLS CUI [2]
C0033573
UMLS CUI [3]
C2348970
use of androgen deprivation therapy. use of 5-alpha-reductase inhibitors is permitted
Beschrijving

Antiandrogen therapy | 5-alpha Reductase Inhibitors allowed

Datatype

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2,1]
C2936788
UMLS CUI [2,2]
C0683607
poor baseline urinary function defined as international prostate symptom score (ipss) >19
Beschrijving

Urinary function Poor International Prostate Symptom Score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042034
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C1998280
contra-indication to radical prostate radiotherapy
Beschrijving

Medical contraindication Radiotherapy to prostate Radical

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0948317
UMLS CUI [1,3]
C0439807
significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Beschrijving

Comorbidity Significant | Patient Inappropriate General Anesthesia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0002915
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Similar models

Eligibility Prostate Cancer NCT02342054

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men older than 18 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
histologically confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Disease TNM clinical staging
Item
clinical stage t1c/t2a disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Disease Low Risk | Disease Intermediate Risk | Gleason score | Prostate specific antigen measurement
Item
low and intermediate risk disease defined as either gleason 6 or gleason 7 and psa < 20 ng/ml.
boolean
C0012634 (UMLS CUI [1,1])
C3538919 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C3640764 (UMLS CUI [2,2])
C3203027 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
Prostate volume Ultrasonography | Prostate volume CT | Prostate volume MRI
Item
prostate volume < 60 cc as determined by ultrasound, ct or mri
boolean
C1441416 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C1441416 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C1441416 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy of more than 10 years
boolean
C0023671 (UMLS CUI [1])
Informed Consent Willing
Item
willing to give informed consent to participate in this clinical trial
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Expanded Prostate Cancer Index Composite Completion
Item
able and willing to complete expanded prostate index composite (epic) questionnaire
boolean
C3810535 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) of 0 - 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent Competent
Item
give competent informed consent to participate in this trial.
boolean
C0021430 (UMLS CUI [1,1])
C0086035 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of lymph node | Distant metastasis
Item
documented nodal or distant metastases
boolean
C0686619 (UMLS CUI [1])
C1269798 (UMLS CUI [2])
Radiotherapy to pelvis
Item
previous pelvic radiotherapy
boolean
C1536155 (UMLS CUI [1])
Transurethral Resection of Prostate | Prostatectomy | High-Intensity Focused Ultrasound Ablation
Item
previous trans-urethral resection of prostate, previous prostatectomy or hifu
boolean
C0040771 (UMLS CUI [1])
C0033573 (UMLS CUI [2])
C2348970 (UMLS CUI [3])
Antiandrogen therapy | 5-alpha Reductase Inhibitors allowed
Item
use of androgen deprivation therapy. use of 5-alpha-reductase inhibitors is permitted
boolean
C0279492 (UMLS CUI [1])
C2936788 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Urinary function Poor International Prostate Symptom Score
Item
poor baseline urinary function defined as international prostate symptom score (ipss) >19
boolean
C0042034 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C1998280 (UMLS CUI [1,3])
Medical contraindication Radiotherapy to prostate Radical
Item
contra-indication to radical prostate radiotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0948317 (UMLS CUI [1,2])
C0439807 (UMLS CUI [1,3])
Comorbidity Significant | Patient Inappropriate General Anesthesia
Item
significant medical co-morbidity rendering patient unsuitable for general anaesthetic
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0002915 (UMLS CUI [2,3])
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