ID

35852

Description

Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02425228

Link

https://clinicaltrials.gov/show/NCT02425228

Keywords

Versions (1)
  1. 3/27/19 3/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 27, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Elevated PSA NCT02425228

English

Eligibility Elevated PSA NCT02425228

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men undergoing a first-time prostate biopsy driven by psa elevation to rule out cancer.
Description

Biopsy of prostate Firstly Due to Raised prostate specific antigen

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C1279901
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0178415
psa 2.5 - 20 ng/ml
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
prostate volume 20 - 100 cc
Description

Prostate volume

Data type

boolean

Alias
UMLS CUI [1]
C1441416
no prior ablation or turp
Description

Ablation Previous Absent | Transurethral Resection of Prostate Previous Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0040771
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0332197
able to tolerate mri
Description

Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1]
C0024485
t1c suspect
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any prior prostate biopsy
Description

Biopsy of prostate Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C0205156
active bleeding disorder or concurrent use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily stopped for at least 7 days before and 7 days after the biopsy
Description

Blood Coagulation Disorders | Coumadin | Anticoagulants | Exception Anticoagulation Therapy Stopped Temporary

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0699129
UMLS CUI [3]
C0003280
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0003281
UMLS CUI [4,3]
C1272691
UMLS CUI [4,4]
C0205374
any prostate ablative procedure, including transurethral resection, photovaporization, or electrovaporization
Description

Prostate ablation | Transurethral Resection | Laser ablation | Transurethral Electrovaporization of Prostate

Data type

boolean

Alias
UMLS CUI [1]
C3804996
UMLS CUI [2]
C1519630
UMLS CUI [3]
C0348007
UMLS CUI [4]
C1136094
any contraindication to mri (contrast allergy, severe claustrophobia, mri-incompatible prosthesis) ,
Description

Medical contraindication Magnetic Resonance Imaging | Contrast media allergy | Claustrophobia Severe | Prosthesis Inappropriate Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0570562
UMLS CUI [3,1]
C0008909
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0175649
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0024485
palpable prostate mass lesion (i.e., stage >t1c suspected)
Description

Prostate mass Lesion Palpable TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0586559
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0522499
UMLS CUI [1,4]
C3258246
any condition that would preclude the subject from getting the required biopsy as stated in the protocol
Description

Condition Excludes Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0005558
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Similar models

Eligibility Elevated PSA NCT02425228

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Biopsy of prostate Firstly Due to Raised prostate specific antigen
Item
men undergoing a first-time prostate biopsy driven by psa elevation to rule out cancer.
boolean
C0194804 (UMLS CUI [1,1])
C1279901 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0178415 (UMLS CUI [1,4])
Prostate specific antigen measurement
Item
psa 2.5 - 20 ng/ml
boolean
C0201544 (UMLS CUI [1])
Prostate volume
Item
prostate volume 20 - 100 cc
boolean
C1441416 (UMLS CUI [1])
Ablation Previous Absent | Transurethral Resection of Prostate Previous Absent
Item
no prior ablation or turp
boolean
C0547070 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0040771 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Magnetic Resonance Imaging
Item
able to tolerate mri
boolean
C0024485 (UMLS CUI [1])
TNM clinical staging
Item
t1c suspect
boolean
C3258246 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Biopsy of prostate Previous
Item
any prior prostate biopsy
boolean
C0194804 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Blood Coagulation Disorders | Coumadin | Anticoagulants | Exception Anticoagulation Therapy Stopped Temporary
Item
active bleeding disorder or concurrent use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily stopped for at least 7 days before and 7 days after the biopsy
boolean
C0005779 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0003280 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0003281 (UMLS CUI [4,2])
C1272691 (UMLS CUI [4,3])
C0205374 (UMLS CUI [4,4])
Prostate ablation | Transurethral Resection | Laser ablation | Transurethral Electrovaporization of Prostate
Item
any prostate ablative procedure, including transurethral resection, photovaporization, or electrovaporization
boolean
C3804996 (UMLS CUI [1])
C1519630 (UMLS CUI [2])
C0348007 (UMLS CUI [3])
C1136094 (UMLS CUI [4])
Medical contraindication Magnetic Resonance Imaging | Contrast media allergy | Claustrophobia Severe | Prosthesis Inappropriate Magnetic Resonance Imaging
Item
any contraindication to mri (contrast allergy, severe claustrophobia, mri-incompatible prosthesis) ,
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0570562 (UMLS CUI [2])
C0008909 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0175649 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Prostate mass Lesion Palpable TNM clinical staging
Item
palpable prostate mass lesion (i.e., stage >t1c suspected)
boolean
C0586559 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0522499 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Condition Excludes Biopsy
Item
any condition that would preclude the subject from getting the required biopsy as stated in the protocol
boolean
C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
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