ID

23177

Beschrijving

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

Trefwoorden

  1. 26-06-17 26-06-17 -
Geüploaded op

26 juni 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Prostate Cancer DRKS00005263 NCT01950871 DRKS00005263

Eligibility Prostate Cancer NCT01950871 DRKS00005263

Inclusion Criteria
Beschrijving

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
Beschrijving

PSA

Datatype

boolean

Alias
UMLS CUI [1]
C0138741
Signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Previous prostate biopsy
Beschrijving

Previous prostate biopsy

Datatype

boolean

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

Prostate Cancer

Datatype

boolean

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

PSA: High Level

Datatype

boolean

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

Urinary tract infection

Datatype

boolean

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

Malignant Neoplasm

Datatype

boolean

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

Operation on Prostate

Datatype

boolean

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

Pelvic radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0436276

Similar models

Eligibility Prostate Cancer NCT01950871 DRKS00005263

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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