ID

31599

Beschrijving

C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00804245

Link

https://clinicaltrials.gov/show/NCT00804245

Trefwoorden

Versies (1)
  1. 11-09-18 11-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00804245

Engels

Eligibility Prostate Cancer NCT00804245

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
prior negative prostate biopsy allowed
Beschrijving

Biopsy of prostate Negative allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0683607
high-risk disease, as defined by one of the following:
Beschrijving

Disease High risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4319571
psa ≥ 20 ng/ml
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
gleason score ≥ 8
Beschrijving

Gleason score

Datatype

boolean

Alias
UMLS CUI [1]
C3203027
digital rectal examination revealing ≥ t2c disease (tumor involving more than one half of one lobe of the prostate)
Beschrijving

Disease TNM clinical staging Digital Rectal Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C1384593
creatinine < 2.0 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
able to tolerate pet scan, ct scan, and bone scan
Beschrijving

Ability Receive PET scan | Ability Receive CT scan | Ability Receive Bone scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0032743
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0085732
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C0203668
able to tolerate iv and oral contrast
Beschrijving

Ability Receive Intravenous contrast | Ability Receive Oral contrast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C4072741
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C0202592
willing to undergo biopsy of positive findings on pet-ct scan, ct scan, or bone scan
Beschrijving

Biopsy PET/CT scan Positive | Biopsy CT scan Positive | Biopsy Bone scan Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1699633
UMLS CUI [1,3]
C1514241
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0040405
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0203668
UMLS CUI [3,3]
C1514241
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
other cancer within the past 5 years (except for nonmelanoma skin cancer)
Beschrijving

Cancer Other | Exception Skin carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
no prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer prior transurethral resection of the prostate allowed
Beschrijving

Prior radiation therapy Prostate carcinoma | Prior Hormone Therapy Prostate carcinoma | Operative Surgical Procedures Prostate carcinoma | Exception Biopsy | Cold Therapy Prostate carcinoma | Transurethral Resection of Prostate allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1514460
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0600139
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0005558
UMLS CUI [5,1]
C0010412
UMLS CUI [5,2]
C0600139
UMLS CUI [6,1]
C0040771
UMLS CUI [6,2]
C0683607
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Similar models

Eligibility Prostate Cancer NCT00804245

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Biopsy of prostate Negative allowed
Item
prior negative prostate biopsy allowed
boolean
C0194804 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Disease High risk
Item
high-risk disease, as defined by one of the following:
boolean
C0012634 (UMLS CUI [1,1])
C4319571 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
psa ≥ 20 ng/ml
boolean
C0201544 (UMLS CUI [1])
Gleason score
Item
gleason score ≥ 8
boolean
C3203027 (UMLS CUI [1])
Disease TNM clinical staging Digital Rectal Examination
Item
digital rectal examination revealing ≥ t2c disease (tumor involving more than one half of one lobe of the prostate)
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1384593 (UMLS CUI [1,3])
Creatinine measurement, serum
Item
creatinine < 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Ability Receive PET scan | Ability Receive CT scan | Ability Receive Bone scan
Item
able to tolerate pet scan, ct scan, and bone scan
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0085732 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0203668 (UMLS CUI [3,3])
Ability Receive Intravenous contrast | Ability Receive Oral contrast
Item
able to tolerate iv and oral contrast
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C4072741 (UMLS CUI [1,3])
C0085732 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C0202592 (UMLS CUI [2,3])
Biopsy PET/CT scan Positive | Biopsy CT scan Positive | Biopsy Bone scan Positive
Item
willing to undergo biopsy of positive findings on pet-ct scan, ct scan, or bone scan
boolean
C0005558 (UMLS CUI [1,1])
C1699633 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0005558 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Skin carcinoma
Item
other cancer within the past 5 years (except for nonmelanoma skin cancer)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Prior radiation therapy Prostate carcinoma | Prior Hormone Therapy Prostate carcinoma | Operative Surgical Procedures Prostate carcinoma | Exception Biopsy | Cold Therapy Prostate carcinoma | Transurethral Resection of Prostate allowed
Item
no prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer prior transurethral resection of the prostate allowed
boolean
C0279134 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1514460 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C0010412 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C0040771 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
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