ID

36883

Beschreibung

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

Stichworte

Versionen (1)
  1. 18.06.19 18.06.19 -
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See clinicaltrials.gov

Hochgeladen am

18. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02342054

Englisch

Eligibility Prostate Cancer NCT02342054

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men older than 18 years old
Beschreibung

Gender | Age

Datentyp

boolean

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

Adenocarcinoma of prostate

Datentyp

boolean

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

Disease TNM clinical staging

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Prostate volume Ultrasonography | Prostate volume CT | Prostate volume MRI

Datentyp

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
Beschreibung

Life Expectancy

Datentyp

boolean

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

Informed Consent Willing

Datentyp

boolean

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

Expanded Prostate Cancer Index Composite Completion

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Informed Consent Competent

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented nodal or distant metastases
Beschreibung

Secondary malignant neoplasm of lymph node | Distant metastasis

Datentyp

boolean

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

Radiotherapy to pelvis

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Antiandrogen therapy | 5-alpha Reductase Inhibitors allowed

Datentyp

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
Beschreibung

Urinary function Poor International Prostate Symptom Score

Datentyp

boolean

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

Medical contraindication Radiotherapy to prostate Radical

Datentyp

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
Beschreibung

Comorbidity Significant | Patient Inappropriate General Anesthesia

Datentyp

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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Ähnliche Modelle

Eligibility Prostate Cancer NCT02342054

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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