ID

17184

Beschrijving

A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00401765

Link

https://clinicaltrials.gov/show/NCT00401765

Trefwoorden

  1. 30-08-16 30-08-16 -
Geüploaded op

30 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Prostatic Neoplasms NCT00401765

Eligibility Prostatic Neoplasms NCT00401765

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate
Beschrijving

adenocarcinoma of the prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
radiologically documented metastatic disease
Beschrijving

metastatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
no prior systemic chemotherapy for metastatic hormone refractory prostate cancer
Beschrijving

systemic chemotherapy for metastatic hormone refractory prostate cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1328504
progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: transaxial imaging tumor progression, rise in 2 consecutive prostate-specifec antigen (psa) values obtained at least 7 days apart or radionucleotide bone scan progression
Beschrijving

progressive hormone-refractory disease

Datatype

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2,1]
C0677932
UMLS CUI [2,2]
C0040405
UMLS CUI [3]
C0201544
UMLS CUI [4,1]
C0677932
UMLS CUI [4,2]
C0203668
karnofsky performance status of greater than or equal to 60
Beschrijving

karnofsky performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prostate cancer that does not express serum psa or is less than 5.0 ng/ml at screening
Beschrijving

psa

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer
Beschrijving

Investigational agent

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years
Beschrijving

malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
known central nervous system metastases
Beschrijving

central nervous system metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
received any over-the-counter or herbal treatment for prostate cancer (eg, pc spes [an herbal refined powder]) within 4 weeks prior to screening.
Beschrijving

over-the-counter or herbal treatment for prostate cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0242388
UMLS CUI [2,2]
C0600139

Similar models

Eligibility Prostatic Neoplasms NCT00401765

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
adenocarcinoma of the prostate
Item
histologically or cytologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
metastatic disease
Item
radiologically documented metastatic disease
boolean
C0027627 (UMLS CUI [1])
systemic chemotherapy for metastatic hormone refractory prostate cancer
Item
no prior systemic chemotherapy for metastatic hormone refractory prostate cancer
boolean
C1883256 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
progressive hormone-refractory disease
Item
progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: transaxial imaging tumor progression, rise in 2 consecutive prostate-specifec antigen (psa) values obtained at least 7 days apart or radionucleotide bone scan progression
boolean
C1328504 (UMLS CUI [1])
C0677932 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])
C0677932 (UMLS CUI [4,1])
C0203668 (UMLS CUI [4,2])
karnofsky performance status
Item
karnofsky performance status of greater than or equal to 60
boolean
C0206065 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
psa
Item
prostate cancer that does not express serum psa or is less than 5.0 ng/ml at screening
boolean
C0201544 (UMLS CUI [1])
Investigational agent
Item
received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer
boolean
C0013230 (UMLS CUI [1])
malignancy
Item
prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years
boolean
C0006826 (UMLS CUI [1])
central nervous system metastases
Item
known central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
over-the-counter or herbal treatment for prostate cancer
Item
received any over-the-counter or herbal treatment for prostate cancer (eg, pc spes [an herbal refined powder]) within 4 weeks prior to screening.
boolean
C0013231 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0242388 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])

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