ID

36935

Description

Improving Prostate Cancer Detection Using MRI-Targeted TRUS-Guided Biopsy; ODM derived from: https://clinicaltrials.gov/show/NCT02488096

Link

https://clinicaltrials.gov/show/NCT02488096

Keywords

Versions (1)
  1. 6/22/19 6/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02488096

English

Eligibility Prostate Cancer NCT02488096

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
referred for an ultrasound-guided prostate biopsy
Description

Referral for US scan and biopsy of prostate

Data type

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C1690523
indication 1: men without a history of prostate cancer referred to the pac for a biopsy who have a history of 1 negative biopsy who are being referred for a follow-up biopsy
Description

Gender | Medical History Absent Prostate carcinoma | Referral to Biopsy | Medical History Biopsy Negative | Referral to Follow-up Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0600139
UMLS CUI [3,1]
C2585021
UMLS CUI [3,2]
C0005558
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0005558
UMLS CUI [4,3]
C1513916
UMLS CUI [5,1]
C2585021
UMLS CUI [5,2]
C1522577
UMLS CUI [5,3]
C0005558
indication 2: men who have a history of diagnosis of prostate cancer and are currently on active surveillance under the care of an oncologist who are referred to the pac for a follow-up biopsy
Description

Gender | Medical History Prostate carcinoma | Patient observation Oncologist | Referral to Follow-up Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0700325
UMLS CUI [3,2]
C0259990
UMLS CUI [4,1]
C2585021
UMLS CUI [4,2]
C1522577
UMLS CUI [4,3]
C0005558
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are unable to consent on their own behalf
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
less than 3 months since previous biopsy (to avoid inflammation and hemorrhage confounding mri image)
Description

Biopsy Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0332185
a history of treatment for prostate cancer (including surgery, chemotherapy or radiotherapy)
Description

Therapeutic procedure Prostate carcinoma | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
emergent/urgent biopsy referrals
Description

Referral for Emergency Biopsy | Referral for Biopsy Urgent

Data type

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C2585524
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0439609
history of urinary tract infections or prostatitis in the last 3 months
Description

Urinary tract infection | Prostatitis

Data type

boolean

Alias
UMLS CUI [1]
C0042029
UMLS CUI [2]
C0033581
contraindications to mri:
Description

Medical contraindication MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
ferromagnetic or otherwise non-mri compatible aneurysm clips
Description

Aneurysm clip Ferromagnet | Aneurysm clip Incompatibility MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0179977
UMLS CUI [1,2]
C3178787
UMLS CUI [2,1]
C0179977
UMLS CUI [2,2]
C0679426
UMLS CUI [2,3]
C0024485
the presence of an implanted pacemaker or implanted defibrillator device
Description

Artificial cardiac pacemaker | Defibrillator implant

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0850291
contraindication to receiving gadolinium containing contrast for the which may include past or current kidney disease or injury or kidney transplant
Description

Medical contraindication Gadolinium-based Contrast Agent | Kidney Disease | Injury of kidney | Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3249258
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0160420
UMLS CUI [4]
C0022671
severe claustrophobia
Description

Claustrophobia Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
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Similar models

Eligibility Prostate Cancer NCT02488096

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Referral for US scan and biopsy of prostate
Item
referred for an ultrasound-guided prostate biopsy
boolean
C2585524 (UMLS CUI [1,1])
C1690523 (UMLS CUI [1,2])
Gender | Medical History Absent Prostate carcinoma | Referral to Biopsy | Medical History Biopsy Negative | Referral to Follow-up Biopsy
Item
indication 1: men without a history of prostate cancer referred to the pac for a biopsy who have a history of 1 negative biopsy who are being referred for a follow-up biopsy
boolean
C0079399 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C2585021 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C0262926 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C1513916 (UMLS CUI [4,3])
C2585021 (UMLS CUI [5,1])
C1522577 (UMLS CUI [5,2])
C0005558 (UMLS CUI [5,3])
Gender | Medical History Prostate carcinoma | Patient observation Oncologist | Referral to Follow-up Biopsy
Item
indication 2: men who have a history of diagnosis of prostate cancer and are currently on active surveillance under the care of an oncologist who are referred to the pac for a follow-up biopsy
boolean
C0079399 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0700325 (UMLS CUI [3,1])
C0259990 (UMLS CUI [3,2])
C2585021 (UMLS CUI [4,1])
C1522577 (UMLS CUI [4,2])
C0005558 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable
Item
are unable to consent on their own behalf
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Biopsy Recent
Item
less than 3 months since previous biopsy (to avoid inflammation and hemorrhage confounding mri image)
boolean
C0005558 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Therapeutic procedure Prostate carcinoma | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure
Item
a history of treatment for prostate cancer (including surgery, chemotherapy or radiotherapy)
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Referral for Emergency Biopsy | Referral for Biopsy Urgent
Item
emergent/urgent biopsy referrals
boolean
C2585524 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C2585524 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0439609 (UMLS CUI [2,3])
Urinary tract infection | Prostatitis
Item
history of urinary tract infections or prostatitis in the last 3 months
boolean
C0042029 (UMLS CUI [1])
C0033581 (UMLS CUI [2])
Medical contraindication MRI
Item
contraindications to mri:
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Aneurysm clip Ferromagnet | Aneurysm clip Incompatibility MRI
Item
ferromagnetic or otherwise non-mri compatible aneurysm clips
boolean
C0179977 (UMLS CUI [1,1])
C3178787 (UMLS CUI [1,2])
C0179977 (UMLS CUI [2,1])
C0679426 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Artificial cardiac pacemaker | Defibrillator implant
Item
the presence of an implanted pacemaker or implanted defibrillator device
boolean
C0030163 (UMLS CUI [1])
C0850291 (UMLS CUI [2])
Medical contraindication Gadolinium-based Contrast Agent | Kidney Disease | Injury of kidney | Kidney Transplantation
Item
contraindication to receiving gadolinium containing contrast for the which may include past or current kidney disease or injury or kidney transplant
boolean
C1301624 (UMLS CUI [1,1])
C3249258 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0160420 (UMLS CUI [3])
C0022671 (UMLS CUI [4])
Claustrophobia Severe
Item
severe claustrophobia
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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