ID

23638

Beschrijving

Sandostatin for Patients With Androgen Independent Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00510224

Link

https://clinicaltrials.gov/show/NCT00510224

Trefwoorden

  1. 10-07-17 10-07-17 -
Geüploaded op

10 juli 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00510224

Eligibility Prostate Cancer NCT00510224

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate.
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
biochemical disease progression following androgen deprivation and therapy with at least one antiandrogen defined as three rises in psa with psa determinations at least 4 weeks apart and each psa value > 0.2 ng/ml.
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C1515985
UMLS CUI [1,3]
C0138741
four weeks since prior therapy with flutamide.
Beschrijving

ID.3

Datatype

boolean

Alias
UMLS CUI [1]
C0016384
six weeks since prior therapy with bicalutamide or nilutamide.
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1,1]
C0285590
UMLS CUI [1,2]
C0068771
current psa > 5 ng/ml.
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
testosterone <50 ng/dl.
Beschrijving

ID.6

Datatype

boolean

sgpt (alt) < 1.5 times upper limit of normal.
Beschrijving

ID.7

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
fasting blood glucose > 60 mg/dl.
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1]
C0428568
ecog performance status 0, 1 or 2.
Beschrijving

ID.9

Datatype

boolean

no visceral or bony metastatic disease (lymph node only metastases are allowed).
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
no prior chemotherapy for prostate cancer.
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
no current treatment with insulin or an oral hypoglycemic.
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0359086
no history of treatment with octreotide analogs for prostate cancer.
Beschrijving

ID.13

Datatype

boolean

Alias
UMLS CUI [1]
C0279440
no nyha class 3 or 4 cardiac status.
Beschrijving

ID.14

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
diabetes mellitus requiring medical therapy and/or that which is not controlled by dietary means (hba1c<6.0).
Beschrijving

ID.15

Datatype

boolean

Alias
UMLS CUI [1]
C0421258
a history of gallstones that has been clinically significant. patients who have undergone cholecystectomy are eligible.
Beschrijving

ID.16

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008320
UMLS CUI [1,2]
C1561969
other concomitant medical or psychiatric condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements.
Beschrijving

ID.17

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1321605
prior treatment with chemotherapy for prostate cancer.
Beschrijving

ID.18

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
no current treatment with saw palmetto, or proscar. patients must be off these medicines for more than 4 weeks.
Beschrijving

ID.19

Datatype

boolean

Alias
UMLS CUI [1,1]
C0771607
UMLS CUI [1,2]
C0678149

Similar models

Eligibility Prostate Cancer NCT00510224

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
histologically confirmed adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
ID.2
Item
biochemical disease progression following androgen deprivation and therapy with at least one antiandrogen defined as three rises in psa with psa determinations at least 4 weeks apart and each psa value > 0.2 ng/ml.
boolean
C0279492 (UMLS CUI [1,1])
C1515985 (UMLS CUI [1,2])
C0138741 (UMLS CUI [1,3])
ID.3
Item
four weeks since prior therapy with flutamide.
boolean
C0016384 (UMLS CUI [1])
ID.4
Item
six weeks since prior therapy with bicalutamide or nilutamide.
boolean
C0285590 (UMLS CUI [1,1])
C0068771 (UMLS CUI [1,2])
ID.5
Item
current psa > 5 ng/ml.
boolean
C0201544 (UMLS CUI [1])
ID.6
Item
testosterone <50 ng/dl.
boolean
ID.7
Item
sgpt (alt) < 1.5 times upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
ID.8
Item
fasting blood glucose > 60 mg/dl.
boolean
C0428568 (UMLS CUI [1])
ID.9
Item
ecog performance status 0, 1 or 2.
boolean
ID.10
Item
no visceral or bony metastatic disease (lymph node only metastases are allowed).
boolean
C0027627 (UMLS CUI [1])
ID.11
Item
no prior chemotherapy for prostate cancer.
boolean
C1514457 (UMLS CUI [1])
ID.12
Item
no current treatment with insulin or an oral hypoglycemic.
boolean
C0021641 (UMLS CUI [1,1])
C0359086 (UMLS CUI [1,2])
ID.13
Item
no history of treatment with octreotide analogs for prostate cancer.
boolean
C0279440 (UMLS CUI [1])
ID.14
Item
no nyha class 3 or 4 cardiac status.
boolean
Item Group
C0680251 (UMLS CUI)
ID.15
Item
diabetes mellitus requiring medical therapy and/or that which is not controlled by dietary means (hba1c<6.0).
boolean
C0421258 (UMLS CUI [1])
ID.16
Item
a history of gallstones that has been clinically significant. patients who have undergone cholecystectomy are eligible.
boolean
C0008320 (UMLS CUI [1,1])
C1561969 (UMLS CUI [1,2])
ID.17
Item
other concomitant medical or psychiatric condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements.
boolean
C0012634 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
ID.18
Item
prior treatment with chemotherapy for prostate cancer.
boolean
C1514457 (UMLS CUI [1])
ID.19
Item
no current treatment with saw palmetto, or proscar. patients must be off these medicines for more than 4 weeks.
boolean
C0771607 (UMLS CUI [1,1])
C0678149 (UMLS CUI [1,2])

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