ID

15861

Description

Active Surveillance in Prostate Cancer, Imaging to Detect Radiographic Progression as an Endpoint (ASPIRE); ODM derived from: https://clinicaltrials.gov/show/NCT02425592

Link

https://clinicaltrials.gov/show/NCT02425592

Keywords

Versions (1)
  1. 6/16/16 6/16/16 -
Uploaded on

June 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02425592

English

Eligibility Prostate Cancer NCT02425592

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 30-80
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
completed mri fusion prostate biopsy either in the past that demonstrated gleason 6 prostate cancer and are either currently enrolled in active surveillance or are interested in active surveillance, or have completed an mri fusion prostate biopsy at the first visit that demonstrates gleason 6 prostate cancer and are interested in active surveillance
Description

MRI Ultrasound Fusion Guided Biopsy | Gleason Grading System | Prostate carcinoma | Active surveillance

Data type

boolean

Alias
UMLS CUI [1]
C3898501
UMLS CUI [2]
C0332326
UMLS CUI [3]
C0600139
UMLS CUI [4]
C1827061
diagnosed with gleason 6 prostate cancer
Description

Prostate carcinoma | Gleason Grading System

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C0332326
psa <20
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
<ct3 prostate cancer
Description

Prostate carcinoma | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C3258246
ability to receive an mri with iv gadolinium contrast
Description

Magnetic Resonance Imaging | Gadolinium-based Contrast Agent Intravenous Injection | Ability

Data type

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2,1]
C3249258
UMLS CUI [2,2]
C0021494
UMLS CUI [3]
C0085732
life expectancy >10 years (by physician estimate)
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
understanding and willingness to provide consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
english speaking
Description

Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received treatment for prostate cancer (hormone manipulation, surgery, radiation).
Description

Therapeutic procedure Prostate carcinoma | Hormone manipulation | Operative Surgical Procedures | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0586971
UMLS CUI [3]
C0543467
UMLS CUI [4]
C1522449
known metastatic disease
Description

Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C2939420
high risk prostate cancer by epstein criteria
Description

Prostate carcinoma High risk of

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0332167
any gleason 7 or higher prostate cancer on prostate biopsy
Description

Prostate carcinoma | Gleason Grading System | Biopsy of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C0332326
UMLS CUI [3]
C0194804
inability to receive an mri with iv gadolinium contrast
Description

Magnetic Resonance Imaging | Gadolinium-based Contrast Agent Intravenous Injections | Unable

Data type

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2,1]
C3249258
UMLS CUI [2,2]
C0021494
UMLS CUI [3]
C1299582
life expectancy <10 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
unwillingness to undergo monitoring and imaging studies
Description

Clinical study Monitoring Unwilling | Clinical study Imaging Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C1283169
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0008972
UMLS CUI [2,2]
C0079595
UMLS CUI [2,3]
C0558080
non-english speaking
Description

Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
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Similar models

Eligibility Prostate Cancer NCT02425592

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 30-80
boolean
C0001779 (UMLS CUI [1])
MRI Ultrasound Fusion Guided Biopsy | Gleason Grading System | Prostate carcinoma | Active surveillance
Item
completed mri fusion prostate biopsy either in the past that demonstrated gleason 6 prostate cancer and are either currently enrolled in active surveillance or are interested in active surveillance, or have completed an mri fusion prostate biopsy at the first visit that demonstrates gleason 6 prostate cancer and are interested in active surveillance
boolean
C3898501 (UMLS CUI [1])
C0332326 (UMLS CUI [2])
C0600139 (UMLS CUI [3])
C1827061 (UMLS CUI [4])
Prostate carcinoma | Gleason Grading System
Item
diagnosed with gleason 6 prostate cancer
boolean
C0600139 (UMLS CUI [1])
C0332326 (UMLS CUI [2])
Prostate specific antigen measurement
Item
psa <20
boolean
C0201544 (UMLS CUI [1])
Prostate carcinoma | TNM clinical staging
Item
<ct3 prostate cancer
boolean
C0600139 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Magnetic Resonance Imaging | Gadolinium-based Contrast Agent Intravenous Injection | Ability
Item
ability to receive an mri with iv gadolinium contrast
boolean
C0024485 (UMLS CUI [1])
C3249258 (UMLS CUI [2,1])
C0021494 (UMLS CUI [2,2])
C0085732 (UMLS CUI [3])
Life Expectancy
Item
life expectancy >10 years (by physician estimate)
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
understanding and willingness to provide consent
boolean
C0021430 (UMLS CUI [1])
Able to speak English Language
Item
english speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Prostate carcinoma | Hormone manipulation | Operative Surgical Procedures | Therapeutic radiology procedure
Item
received treatment for prostate cancer (hormone manipulation, surgery, radiation).
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0586971 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Metastatic Neoplasm
Item
known metastatic disease
boolean
C2939420 (UMLS CUI [1])
Prostate carcinoma High risk of
Item
high risk prostate cancer by epstein criteria
boolean
C0600139 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
Prostate carcinoma | Gleason Grading System | Biopsy of prostate
Item
any gleason 7 or higher prostate cancer on prostate biopsy
boolean
C0600139 (UMLS CUI [1])
C0332326 (UMLS CUI [2])
C0194804 (UMLS CUI [3])
Magnetic Resonance Imaging | Gadolinium-based Contrast Agent Intravenous Injections | Unable
Item
inability to receive an mri with iv gadolinium contrast
boolean
C0024485 (UMLS CUI [1])
C3249258 (UMLS CUI [2,1])
C0021494 (UMLS CUI [2,2])
C1299582 (UMLS CUI [3])
Life Expectancy
Item
life expectancy <10 years
boolean
C0023671 (UMLS CUI [1])
Clinical study Monitoring Unwilling | Clinical study Imaging Unwilling
Item
unwillingness to undergo monitoring and imaging studies
boolean
C0008972 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0008972 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Able to speak English Language
Item
non-english speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
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