ID

36641

Description

Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach; ODM derived from: https://clinicaltrials.gov/show/NCT01138527

Link

https://clinicaltrials.gov/show/NCT01138527

Keywords

Versions (2)
  1. 1/17/19 1/17/19 -
  2. 5/27/19 5/27/19 -
Copyright Holder

Radboud University

Uploaded on

May 27, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Prostate Cancer Localization With Multiparametric MR (PCa-MAP) NCT01138527

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy-proven diagnosis of adenocarcinoma of the prostate
Description

biopsy-proven diagnosis of adenocarcinoma of the prostate

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0007112
subject will sign a consent form prior to study entry
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
radical prostatectomy and histopathological exam planned
Description

radical prostatectomy and histopathological exam planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C0019638
the time interval between last biopsy and the MR exam must be at least 4 weeks
Description

interval between last biopsy and MR

Data type

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0005558
UMLS CUI [1,4]
C0024485
the time interval between MR exam and radical prostatectomy should not exceed 12 weeks
Description

interval between MR exam and radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0194810
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who are unable to give valid informed consent
Description

unable to give informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams
Description

unwilling or unable to undergo MR, including contra-indications

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0024485
therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy).
Description

therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate, including radiation therapy, cryo-therapy, thermal-therapy, medication, hormonal therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0033572
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C1706276
UMLS CUI [2,4]
C0033572
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0033572
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0178784
UMLS CUI [4,3]
C1706276
UMLS CUI [4,4]
C0033572
UMLS CUI [5]
C1522449
UMLS CUI [6]
C4551716
UMLS CUI [7]
C0454527
UMLS CUI [8]
C0013216
UMLS CUI [9]
C0279025
patients under hormone deprivation therapy
Description

hormone deprivation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0279492
Back to the top of the page

Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
biopsy-proven diagnosis of adenocarcinoma of the prostate
Item
biopsy-proven diagnosis of adenocarcinoma of the prostate
boolean
C0005558 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0007112 (UMLS CUI [1,3])
informed consent
Item
subject will sign a consent form prior to study entry
boolean
C0021430 (UMLS CUI [1])
radical prostatectomy and histopathological exam planned
Item
radical prostatectomy and histopathological exam planned
boolean
C0194810 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C0019638 (UMLS CUI [2,2])
interval between last biopsy and MR
Item
the time interval between last biopsy and the MR exam must be at least 4 weeks
boolean
C1272706 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
interval between MR exam and radical prostatectomy
Item
the time interval between MR exam and radical prostatectomy should not exceed 12 weeks
boolean
C1272706 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
unable to give informed consent
Item
subjects who are unable to give valid informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
unwilling or unable to undergo MR, including contra-indications
Item
subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams
boolean
C0024485 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate, including radiation therapy, cryo-therapy, thermal-therapy, medication, hormonal therapy
Item
therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy).
boolean
C0087111 (UMLS CUI [1,1])
C0033572 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C1706276 (UMLS CUI [2,3])
C0033572 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3,1])
C0033572 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0178784 (UMLS CUI [4,2])
C1706276 (UMLS CUI [4,3])
C0033572 (UMLS CUI [4,4])
C1522449 (UMLS CUI [5])
C4551716 (UMLS CUI [6])
C0454527 (UMLS CUI [7])
C0013216 (UMLS CUI [8])
C0279025 (UMLS CUI [9])
hormone deprivation therapy
Item
patients under hormone deprivation therapy
boolean
C0521116 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial