ID

38370

Beskrivning

A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01890096

Länk

https://clinicaltrials.gov/show/NCT01890096

Nyckelord

Versioner (1)
  1. 2019-10-13 2019-10-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma of the Prostate NCT01890096

Engelsk

Eligibility Carcinoma of the Prostate NCT01890096

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of adenocarcinoma of the prostate
Beskrivning

Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
low and intermediate risk disease defined as either gleason 6 or gleason 7 and psa < 20ng/ml. psa to be drawn within 60 days of registration
Beskrivning

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

Datatyp

boolean

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

Prostate volume Ultrasonography | Prostate volume CT | Prostate volume MRI

Datatyp

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
willing to give informed consent ot participate in this clinical trial
Beskrivning

Informed Consent

Datatyp

boolean

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

EPIC Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3810535
UMLS CUI [1,2]
C0205197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented nodal or distant metastases
Beskrivning

Secondary malignant neoplasm of lymph node | Distant metastasis

Datatyp

boolean

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

Radiotherapy to pelvis

Datatyp

boolean

Alias
UMLS CUI [1]
C1536155
previous trans-urethral resection of prostate, previous prostatectomy or highly focused ultrasound (hifu)
Beskrivning

Transurethral Resection of Prostate | Prostatectomy | High intensity focused ultrasound

Datatyp

boolean

Alias
UMLS CUI [1]
C0040771
UMLS CUI [2]
C0033573
UMLS CUI [3]
C0441583
use of androgen deprivation therapy. use of 5-alpha reductase inhibitors is permitted
Beskrivning

Antiandrogen therapy | 5-alpha Reductase Inhibitors allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2,1]
C2936788
UMLS CUI [2,2]
C0683607
poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
Beskrivning

Urinary function Poor | Therapeutic radiology procedure Connective Tissue Disease | Therapeutic radiology procedure Inflammatory Bowel Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042034
UMLS CUI [1,2]
C0542537
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0009782
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0021390
significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Beskrivning

Comorbidity Significant | Patient Inappropriate General Anesthesia

Datatyp

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 Carcinoma of the Prostate NCT01890096

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Low Risk Disease Gleason score | Intermediate Risk Disease Gleason score | Prostate specific antigen measurement
Item
low and intermediate risk disease defined as either gleason 6 or gleason 7 and psa < 20ng/ml. psa to be drawn within 60 days of registration
boolean
C3538919 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C3203027 (UMLS CUI [1,3])
C3640764 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C3203027 (UMLS CUI [2,3])
C0201544 (UMLS CUI [3])
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])
Informed Consent
Item
willing to give informed consent ot participate in this clinical trial
boolean
C0021430 (UMLS CUI [1])
EPIC Completion
Item
able and willing to complete expanded prostate index composite (epic) questionnaire
boolean
C3810535 (UMLS CUI [1,1])
C0205197 (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
Item
previous trans-urethral resection of prostate, previous prostatectomy or highly focused ultrasound (hifu)
boolean
C0040771 (UMLS CUI [1])
C0033573 (UMLS CUI [2])
C0441583 (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 | Therapeutic radiology procedure Connective Tissue Disease | Therapeutic radiology procedure Inflammatory Bowel Disease
Item
poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
boolean
C0042034 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0009782 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0021390 (UMLS CUI [3,2])
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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