ID

15591

Description

Selenium in Preventing Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00978718

Link

https://clinicaltrials.gov/show/NCT00978718

Keywords

Versions (1)
  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00978718

English

Eligibility Prostate Cancer NCT00978718

1 forms  
Criteria
Description

Criteria

clinical indicators consistent with the community standards of medical care that would justify a biopsy of the prostate for the diagnosis of cancer, including ≥ 1 of the following:
Description

prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C0600139
psa level above the absolute value of 4 ng/ml or above a published age-ethnic adjusted psa level appropriate for the community
Description

elevated PSA level

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C3163633
rising psa that should represent a clinically significant psa velocity (e.g., an estimated annual change in the psa velocity ≥ 0.75 ng/ml)
Description

significant psa velocity

Data type

boolean

Alias
UMLS CUI [1]
C1518823
abnormal digital rectal examination of the prostate that identifies a clinically significant change in the prostate (e.g., a prostate nodule or a change in the firmness of the prostate)
Description

clinically significant change in the prostate

Data type

boolean

Alias
UMLS CUI [1]
C1096657
documentation of the clinical assessment that justified the prostate biopsy that allows classification of the patient to high-risk groups
Description

prostate biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0194804
prostate biopsy negative for cancer within the past 12 months
Description

prostate biopsy negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C0205160
prostate biopsy negative for high-grade prostatic intraepithelial neoplasia (pin)
Description

negative for high-grade prostatic intraepithelial neoplasia

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C0205160
UMLS CUI [1,3]
C1168327
pin allowed provided it is grade 1
Description

PIN grade 1

Data type

boolean

Alias
UMLS CUI [1,1]
C0282612
UMLS CUI [1,2]
C0687695
creatinine < 2 times upper limit of normal (uln)
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0010294
bilirubin < 2 times uln
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0005437
sgot and sgpt < 2 times uln
Description

sgot and sgpt

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
alkaline phosphatase < 2 times uln
Description

alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
no history of a prior malignancy except for the following:
Description

history of malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
adequately treated basal cell or squamous cell carcinoma
Description

basal cell or squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C0087111
adequately treated (i.e., complete surgical removal with negative margins) stage i cancer from which the patient is currently in complete remission
Description

complete remission

Data type

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0087111
any other cancer from which the patient has been disease-free for 5 years
Description

other cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0242793
no prior systemic chemotherapy or radiotherapy
Description

chemotherapy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
at least 90 days since prior and no other concurrent selenium > 55 μg/day as a dietary supplement (including multivitamin supplements)
Description

concurrent selenium

Data type

boolean

Alias
UMLS CUI [1]
C0521939
more than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modifications, exercise)
Description

concurrent participation in any other clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Prostate Cancer NCT00978718

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
prostate cancer
Item
clinical indicators consistent with the community standards of medical care that would justify a biopsy of the prostate for the diagnosis of cancer, including ≥ 1 of the following:
boolean
C0600139 (UMLS CUI [1])
elevated PSA level
Item
psa level above the absolute value of 4 ng/ml or above a published age-ethnic adjusted psa level appropriate for the community
boolean
C0138741 (UMLS CUI [1,1])
C3163633 (UMLS CUI [1,2])
significant psa velocity
Item
rising psa that should represent a clinically significant psa velocity (e.g., an estimated annual change in the psa velocity ≥ 0.75 ng/ml)
boolean
C1518823 (UMLS CUI [1])
clinically significant change in the prostate
Item
abnormal digital rectal examination of the prostate that identifies a clinically significant change in the prostate (e.g., a prostate nodule or a change in the firmness of the prostate)
boolean
C1096657 (UMLS CUI [1])
prostate biopsy
Item
documentation of the clinical assessment that justified the prostate biopsy that allows classification of the patient to high-risk groups
boolean
C0194804 (UMLS CUI [1])
prostate biopsy negative
Item
prostate biopsy negative for cancer within the past 12 months
boolean
C0194804 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
negative for high-grade prostatic intraepithelial neoplasia
Item
prostate biopsy negative for high-grade prostatic intraepithelial neoplasia (pin)
boolean
C0194804 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C1168327 (UMLS CUI [1,3])
PIN grade 1
Item
pin allowed provided it is grade 1
boolean
C0282612 (UMLS CUI [1,1])
C0687695 (UMLS CUI [1,2])
creatinine
Item
creatinine < 2 times upper limit of normal (uln)
boolean
C0010294 (UMLS CUI [1])
bilirubin
Item
bilirubin < 2 times uln
boolean
C0005437 (UMLS CUI [1])
sgot and sgpt
Item
sgot and sgpt < 2 times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
alkaline phosphatase
Item
alkaline phosphatase < 2 times uln
boolean
C0201850 (UMLS CUI [1])
history of malignancy
Item
no history of a prior malignancy except for the following:
boolean
C0006826 (UMLS CUI [1])
basal cell or squamous cell carcinoma
Item
adequately treated basal cell or squamous cell carcinoma
boolean
C0007117 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0007137 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
complete remission
Item
adequately treated (i.e., complete surgical removal with negative margins) stage i cancer from which the patient is currently in complete remission
boolean
C0677874 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
other cancer
Item
any other cancer from which the patient has been disease-free for 5 years
boolean
C1707251 (UMLS CUI [1,1])
C0242793 (UMLS CUI [1,2])
chemotherapy or radiotherapy
Item
no prior systemic chemotherapy or radiotherapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
concurrent selenium
Item
at least 90 days since prior and no other concurrent selenium > 55 μg/day as a dietary supplement (including multivitamin supplements)
boolean
C0521939 (UMLS CUI [1])
concurrent participation in any other clinical trial
Item
more than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modifications, exercise)
boolean
C2348568 (UMLS CUI [1])
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