ID

36859

Description

Prostate Cancer Upgrading Reference Set; ODM derived from: https://clinicaltrials.gov/show/NCT02189486

Link

https://clinicaltrials.gov/show/NCT02189486

Keywords

Versions (1)
  1. 6/17/19 6/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02189486

English

Eligibility Prostate Cancer NCT02189486

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical prostatectomy.
Description

Prostate carcinoma Biopsy of prostate | Radical prostatectomy Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0194804
UMLS CUI [2,1]
C0194810
UMLS CUI [2,2]
C0205539
2. prostate cancer must be graded as gleason 3+3 on the biopsy immediately prior to radical prostatectomy. (secondary eligibility will be established on central review of pathology slides, and blocks if available, at cornell central pathology laboratory to confirm eligibility.)
Description

Prostate carcinoma Gleason score | Biopsy Before Radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3203027
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0194810
3. prostate cancer may have been detected on prior biopsy as well but must not be greater than gleason 3+3. (also requires central pathology laboratory review.)
Description

Prostate carcinoma Gleason score | Biopsy Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3203027
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0205156
4. slides must be available for central pathology laboratory review on any biopsy showing prostate cancer. ffpe blocks may also be requested if available.
Description

Slides Biopsy Prostate carcinoma | Blocks Formalin-fixed paraffin-embedded tissue specimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0681504
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C1533157
UMLS CUI [2,2]
C2711483
5. patient must have selected radical prostatectomy as treatment for prostate cancer.
Description

Radical prostatectomy selected Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C1707391
UMLS CUI [1,3]
C0600139
6. signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. blocks and/or slides from prostate biopsy and from radical prostatectomy must be available for analysis by central pathology laboratory.
Description

Block Specimens Biopsy of prostate | Slides Biopsy of prostate | Block Specimens Radical prostatectomy | Slides Radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C1533157
UMLS CUI [1,2]
C0194804
UMLS CUI [2,1]
C0681504
UMLS CUI [2,2]
C0194804
UMLS CUI [3,1]
C1533157
UMLS CUI [3,2]
C0194810
UMLS CUI [4,1]
C0681504
UMLS CUI [4,2]
C0194810
8. willingness to provide long-term follow-up information regarding additional treatments and cancer status.
Description

Follow-up Information Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C0443252
9. willingness to provide blood and urine specimens prior to radical prostatectomy for placement in the edrn upgrading reference set repository.
Description

Blood specimen prior to Radical prostatectomy | Urine specimen prior to Radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0194810
UMLS CUI [2,1]
C1610733
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0194810
10. willingness to provide demographic and clinical information related to prostate cancer and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).
Description

Information Relationship Prostate carcinoma | Information Relationship Prostate carcinoma Risk | Ethnicity | Family history of prostate cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1533716
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C1533716
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0600139
UMLS CUI [2,4]
C0035647
UMLS CUI [3]
C0015031
UMLS CUI [4]
C1532320
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. gleason score greater than 3+3 on any prior prostate biopsy.
Description

Gleason score Biopsy of prostate Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C3203027
UMLS CUI [1,2]
C0194804
UMLS CUI [1,3]
C0205156
2. any treatment other than radical prostatectomy planned for prostate cancer.
Description

Planned Treatment Prostate carcinoma | Exception Radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C3641097
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0194810
3. prior treatment of the prostate with androgen deprivation, radiation, or other cytotoxic chemotherapy.
Description

Antiandrogen therapy | Therapeutic radiology procedure | Cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0677881
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Similar models

Eligibility Prostate Cancer NCT02189486

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma Biopsy of prostate | Radical prostatectomy Scheduled
Item
1. prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical prostatectomy.
boolean
C0600139 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C0194810 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Prostate carcinoma Gleason score | Biopsy Before Radical prostatectomy
Item
2. prostate cancer must be graded as gleason 3+3 on the biopsy immediately prior to radical prostatectomy. (secondary eligibility will be established on central review of pathology slides, and blocks if available, at cornell central pathology laboratory to confirm eligibility.)
boolean
C0600139 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
Prostate carcinoma Gleason score | Biopsy Previous
Item
3. prostate cancer may have been detected on prior biopsy as well but must not be greater than gleason 3+3. (also requires central pathology laboratory review.)
boolean
C0600139 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Slides Biopsy Prostate carcinoma | Blocks Formalin-fixed paraffin-embedded tissue specimen
Item
4. slides must be available for central pathology laboratory review on any biopsy showing prostate cancer. ffpe blocks may also be requested if available.
boolean
C0681504 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C1533157 (UMLS CUI [2,1])
C2711483 (UMLS CUI [2,2])
Radical prostatectomy selected Prostate carcinoma
Item
5. patient must have selected radical prostatectomy as treatment for prostate cancer.
boolean
C0194810 (UMLS CUI [1,1])
C1707391 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Informed Consent
Item
6. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Block Specimens Biopsy of prostate | Slides Biopsy of prostate | Block Specimens Radical prostatectomy | Slides Radical prostatectomy
Item
7. blocks and/or slides from prostate biopsy and from radical prostatectomy must be available for analysis by central pathology laboratory.
boolean
C1533157 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C0681504 (UMLS CUI [2,1])
C0194804 (UMLS CUI [2,2])
C1533157 (UMLS CUI [3,1])
C0194810 (UMLS CUI [3,2])
C0681504 (UMLS CUI [4,1])
C0194810 (UMLS CUI [4,2])
Follow-up Information Long-term
Item
8. willingness to provide long-term follow-up information regarding additional treatments and cancer status.
boolean
C3274571 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Blood specimen prior to Radical prostatectomy | Urine specimen prior to Radical prostatectomy
Item
9. willingness to provide blood and urine specimens prior to radical prostatectomy for placement in the edrn upgrading reference set repository.
boolean
C0178913 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
C1610733 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
Information Relationship Prostate carcinoma | Information Relationship Prostate carcinoma Risk | Ethnicity | Family history of prostate cancer
Item
10. willingness to provide demographic and clinical information related to prostate cancer and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).
boolean
C1533716 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C1533716 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C0035647 (UMLS CUI [2,4])
C0015031 (UMLS CUI [3])
C1532320 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Gleason score Biopsy of prostate Previous
Item
1. gleason score greater than 3+3 on any prior prostate biopsy.
boolean
C3203027 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Planned Treatment Prostate carcinoma | Exception Radical prostatectomy
Item
2. any treatment other than radical prostatectomy planned for prostate cancer.
boolean
C3641097 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0194810 (UMLS CUI [2,2])
Antiandrogen therapy | Therapeutic radiology procedure | Cytotoxic Chemotherapy
Item
3. prior treatment of the prostate with androgen deprivation, radiation, or other cytotoxic chemotherapy.
boolean
C0279492 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
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