ID

36959

Description

SmartTarget: BIOPSY; ODM derived from: https://clinicaltrials.gov/show/NCT02341677

Link

https://clinicaltrials.gov/show/NCT02341677

Keywords

Versions (1)
  1. 6/24/19 6/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02341677

English

Eligibility Prostatic Neoplasms NCT02341677

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previous trus biopsy with clinical indication for repeat biopsy
Description

TRUS Biopsy | Indication Biopsy Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0205341
discrete lesion on mpmri scoring 3, 4 or 5 on pi-rads scale
Description

Lesion discrete mp-MRI | PI-RADS

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0443299
UMLS CUI [1,3]
C3898221
UMLS CUI [2]
C3897818
an understanding of the english language sufficient to understand written and verbal information about the trial and consent process
Description

Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
Description

Hormone Therapy | Exception 5-alpha Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2936788
men with an irreversible coagulopathy predisposing to bleeding
Description

Blood Coagulation Disorder predisposing Hemorrhage

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0231203
UMLS CUI [1,3]
C0019080
men who are unability to undergo transrectal ultrasonography
Description

Transrectal ultrasound Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
men who have had previous radiation therapy to the pelvis
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
men who have had hifu, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
Description

High intensity focused ultrasound of prostate | Prostate cryoablation | Thermal therapy Prostate | Irreversible Electroporation Prostate | Photochemotherapy Prostate | Other Coding | Microwave therapy to prostate | Transurethral Resection of Prostate Benign Prostatic Hyperplasia | Transurethral vaporization of prostate Benign Prostatic Hyperplasia

Data type

boolean

Alias
UMLS CUI [1]
C0843749
UMLS CUI [2]
C0843747
UMLS CUI [3,1]
C0454527
UMLS CUI [3,2]
C0033572
UMLS CUI [4,1]
C4319935
UMLS CUI [4,2]
C0033572
UMLS CUI [5,1]
C0031740
UMLS CUI [5,2]
C0033572
UMLS CUI [6]
C3846158
UMLS CUI [7]
C0438674
UMLS CUI [8,1]
C0040771
UMLS CUI [8,2]
C1704272
UMLS CUI [9,1]
C3888988
UMLS CUI [9,2]
C1704272
men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
Description

Neoplasm Metastasis Extraprostatic Bone scan | Neoplasm Metastasis Extraprostatic Cross-sectional imaging | Disorder of lymph node Extraprostatic Bone scan | Disorder of lymph node Extraprostatic Cross-sectional imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517078
UMLS CUI [1,3]
C0203668
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1517078
UMLS CUI [2,3]
C3824793
UMLS CUI [3,1]
C0272394
UMLS CUI [3,2]
C1517078
UMLS CUI [3,3]
C0203668
UMLS CUI [4,1]
C0272394
UMLS CUI [4,2]
C1517078
UMLS CUI [4,3]
C3824793
men who are unable to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Prostatic Neoplasms NCT02341677

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
TRUS Biopsy | Indication Biopsy Repeat
Item
previous trus biopsy with clinical indication for repeat biopsy
boolean
C0373345 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Lesion discrete mp-MRI | PI-RADS
Item
discrete lesion on mpmri scoring 3, 4 or 5 on pi-rads scale
boolean
C0221198 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C3898221 (UMLS CUI [1,3])
C3897818 (UMLS CUI [2])
Comprehension English Language
Item
an understanding of the english language sufficient to understand written and verbal information about the trial and consent process
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy | Exception 5-alpha Reductase Inhibitors
Item
men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
boolean
C0279025 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2936788 (UMLS CUI [2,2])
Blood Coagulation Disorder predisposing Hemorrhage
Item
men with an irreversible coagulopathy predisposing to bleeding
boolean
C0005779 (UMLS CUI [1,1])
C0231203 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
Transrectal ultrasound Receive Unable
Item
men who are unability to undergo transrectal ultrasonography
boolean
C0373345 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Radiotherapy to pelvis
Item
men who have had previous radiation therapy to the pelvis
boolean
C1536155 (UMLS CUI [1])
High intensity focused ultrasound of prostate | Prostate cryoablation | Thermal therapy Prostate | Irreversible Electroporation Prostate | Photochemotherapy Prostate | Other Coding | Microwave therapy to prostate | Transurethral Resection of Prostate Benign Prostatic Hyperplasia | Transurethral vaporization of prostate Benign Prostatic Hyperplasia
Item
men who have had hifu, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
boolean
C0843749 (UMLS CUI [1])
C0843747 (UMLS CUI [2])
C0454527 (UMLS CUI [3,1])
C0033572 (UMLS CUI [3,2])
C4319935 (UMLS CUI [4,1])
C0033572 (UMLS CUI [4,2])
C0031740 (UMLS CUI [5,1])
C0033572 (UMLS CUI [5,2])
C3846158 (UMLS CUI [6])
C0438674 (UMLS CUI [7])
C0040771 (UMLS CUI [8,1])
C1704272 (UMLS CUI [8,2])
C3888988 (UMLS CUI [9,1])
C1704272 (UMLS CUI [9,2])
Neoplasm Metastasis Extraprostatic Bone scan | Neoplasm Metastasis Extraprostatic Cross-sectional imaging | Disorder of lymph node Extraprostatic Bone scan | Disorder of lymph node Extraprostatic Cross-sectional imaging
Item
men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
boolean
C0027627 (UMLS CUI [1,1])
C1517078 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C1517078 (UMLS CUI [2,2])
C3824793 (UMLS CUI [2,3])
C0272394 (UMLS CUI [3,1])
C1517078 (UMLS CUI [3,2])
C0203668 (UMLS CUI [3,3])
C0272394 (UMLS CUI [4,1])
C1517078 (UMLS CUI [4,2])
C3824793 (UMLS CUI [4,3])
Informed Consent Unable
Item
men who are unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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