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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 -
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March 27, 2019

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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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