ID

23177

Description

Responsible Party: Advanced Medical Diagnostics s.a. ClinicalTrials.gov Identifier: NCT01950871 History of Changes Other Study ID Numbers: CR2P01127 DRKS00005263 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: September 19, 2013 Last Updated: January 2, 2015 Prostate Guided Biopsy Study Evaluating the Diagnostic Performance of Prostate HistoScanning; ODM derived from: https://clinicaltrials.gov/show/NCT01950871

Link

https://clinicaltrials.gov/show/NCT01950871

Keywords

Versions (1)
  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00005263 NCT01950871 DRKS00005263

English

Eligibility Prostate Cancer NCT01950871 DRKS00005263

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Men at risk of pca scheduled for first biopsy with serum total psa ≤ 20 ng/ml (≤ 10 ng/ml if taking 5-alpha reductase inhibitors) from maximally 3 months ago
Description

PSA

Data type

boolean

Alias
UMLS CUI [1]
C0138741
Signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Previous prostate biopsy
Description

Previous prostate biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C0205156
Confirmed PCa
Description

Prostate Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0600139
PSA > 20 ng/ml (or > 10 ng/ml if taking 5-alpha reductase inhibitors)
Description

PSA: High Level

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C0205250
active urinary tract infection
Description

Urinary tract infection

Data type

boolean

Alias
UMLS CUI [1]
C0042029
presence/history of any confirmed cancer
Description

Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0006826
recent prostatic surgery (past 6 months)
Description

Operation on Prostate

Data type

boolean

Alias
UMLS CUI [1]
C0194790
history of pelvic radiotherapy
Description

Pelvic radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0436276
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Similar models

Eligibility Prostate Cancer NCT01950871 DRKS00005263

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
PSA
Item
Men at risk of pca scheduled for first biopsy with serum total psa ≤ 20 ng/ml (≤ 10 ng/ml if taking 5-alpha reductase inhibitors) from maximally 3 months ago
boolean
C0138741 (UMLS CUI [1])
Informed Consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Previous prostate biopsy
Item
Previous prostate biopsy
boolean
C0194804 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Prostate Cancer
Item
Confirmed PCa
boolean
C0600139 (UMLS CUI [1])
PSA: High Level
Item
PSA > 20 ng/ml (or > 10 ng/ml if taking 5-alpha reductase inhibitors)
boolean
C0138741 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Urinary tract infection
Item
active urinary tract infection
boolean
C0042029 (UMLS CUI [1])
Malignant Neoplasm
Item
presence/history of any confirmed cancer
boolean
C0006826 (UMLS CUI [1])
Operation on Prostate
Item
recent prostatic surgery (past 6 months)
boolean
C0194790 (UMLS CUI [1])
Pelvic radiotherapy
Item
history of pelvic radiotherapy
boolean
C0436276 (UMLS CUI [1])
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