ID

36659

Descrição

Preoperative Magnetic Resonance (MR) Imaging of Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01347320

Link

https://clinicaltrials.gov/show/NCT01347320

Palavras-chave

Versões (3)
  1. 17/01/2019 17/01/2019 -
  2. 27/05/2019 27/05/2019 -
  3. 29/05/2019 29/05/2019 - Sarah Riepenhausen
Titular dos direitos

Oslo University Hospital

Transferido a

29 de maio de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Preoperative MRI of Prostate Cancer NCT01347320

Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients suitable for surgery
Descrição

suitable for surgery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3900053
UMLS CUI [1,2]
C0543467
positive biopsy (Gleason grade >3)
Descrição

biopsy (Gleason graded)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005558
UMLS CUI [2]
C3203027
informed consent
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who do not sign the consent paper for any reason or do not accept the study premises
Descrição

no consent or not accepting the study requirements

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C3641828
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C1514873
patents who want to withdraw for any reason during the study.
Descrição

withdrawal during the study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0422727
patients with contraindications to mri (pacemaker, claustrophobia etc) and/or surgery
Descrição

contraindications to MRI (pacemaker, claustrophobia etc) and/or surgery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0008909
UMLS CUI [3]
C0810633
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0543467
patients who have undergone a high quality MRI examination of the prostate at another radiological center
Descrição

In this situation the MR examination is evaluated together with the surgeon but the patient is not included in the study. In case of a low quality examinations, we will disregard the findings, and include the patient.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0033572
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C0475309
UMLS CUI [2]
C0806487
if the surgeon finds it unacceptable to perform RALP without MRI, because of various reasons (eg. patient demand, too high risk etc) the patient will not be included in the study.
Descrição

surgeon finds it unacceptable to perform RALP without MRI (e.g. patient demand, too high risk)

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0582175
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C4039115
UMLS CUI [1,4]
C0332288
UMLS CUI [1,5]
C0024485
UMLS CUI [2,1]
C0566251
UMLS CUI [2,2]
C1883420
UMLS CUI [2,3]
C0035647
UMLS CUI [3,1]
C0566251
UMLS CUI [3,2]
C0871633
UMLS CUI [3,3]
C0030705
if preoperative MRI reveals extensive tumor invasion into adjacent organ (T4) or skeletal metastases (M1), as these cancer stadiums do not benefit from RALP
Descrição

Tumor invasion into adjacent organs (T staging) or skeletal metastases on preoperative MRI

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0445204
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C1269793
UMLS CUI [1,4]
C0205117
UMLS CUI [1,5]
C0178784
UMLS CUI [2]
C0475455
UMLS CUI [3,1]
C0445204
UMLS CUI [3,2]
C0024485
UMLS CUI [3,3]
C0027627
UMLS CUI [3,4]
C0037253
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
suitable for surgery
Item
all patients suitable for surgery
boolean
C3900053 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
biopsy (Gleason graded)
Item
positive biopsy (Gleason grade >3)
boolean
C0005558 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
no consent or not accepting the study requirements
Item
patients who do not sign the consent paper for any reason or do not accept the study premises
boolean
C0332197 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C3641828 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
withdrawal during the study
Item
patents who want to withdraw for any reason during the study.
boolean
C0422727 (UMLS CUI [1])
contraindications to MRI (pacemaker, claustrophobia etc) and/or surgery
Item
patients with contraindications to mri (pacemaker, claustrophobia etc) and/or surgery
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C0810633 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
previous prostate MRI at another radiological center
Item
patients who have undergone a high quality MRI examination of the prostate at another radiological center
boolean
C0205156 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0033572 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0475309 (UMLS CUI [1,5])
C0806487 (UMLS CUI [2])
surgeon finds it unacceptable to perform RALP without MRI (e.g. patient demand, too high risk)
Item
if the surgeon finds it unacceptable to perform RALP without MRI, because of various reasons (eg. patient demand, too high risk etc) the patient will not be included in the study.
boolean
C0582175 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C4039115 (UMLS CUI [1,3])
C0332288 (UMLS CUI [1,4])
C0024485 (UMLS CUI [1,5])
C0566251 (UMLS CUI [2,1])
C1883420 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
C0566251 (UMLS CUI [3,1])
C0871633 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
Tumor invasion into adjacent organs (T staging) or skeletal metastases on preoperative MRI
Item
if preoperative MRI reveals extensive tumor invasion into adjacent organ (T4) or skeletal metastases (M1), as these cancer stadiums do not benefit from RALP
boolean
C0445204 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1269793 (UMLS CUI [1,3])
C0205117 (UMLS CUI [1,4])
C0178784 (UMLS CUI [1,5])
C0475455 (UMLS CUI [2])
C0445204 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C0037253 (UMLS CUI [3,4])
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