ID

38370

Descrição

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

Link

https://clinicaltrials.gov/show/NCT01890096

Palavras-chave

  1. 13/10/2019 13/10/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

13 de outubro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Carcinoma of the Prostate NCT01890096

Eligibility Carcinoma of the Prostate NCT01890096

Inclusion Criteria
Descrição

Inclusion Criteria

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

Adenocarcinoma of prostate

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Prostate volume Ultrasonography | Prostate volume CT | Prostate volume MRI

Tipo de dados

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
Descrição

Informed Consent

Tipo de dados

boolean

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

EPIC Completion

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented nodal or distant metastases
Descrição

Secondary malignant neoplasm of lymph node | Distant metastasis

Tipo de dados

boolean

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

Radiotherapy to pelvis

Tipo de dados

boolean

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

Transurethral Resection of Prostate | Prostatectomy | High intensity focused ultrasound

Tipo de dados

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
Descrição

Antiandrogen therapy | 5-alpha Reductase Inhibitors allowed

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Comorbidity Significant | Patient Inappropriate General Anesthesia

Tipo de dados

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

Similar models

Eligibility Carcinoma of the Prostate NCT01890096

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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