ID

18942

Beschrijving

Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00103428

Link

https://clinicaltrials.gov/show/NCT00103428

Trefwoorden

Versies (1)
  1. 25-11-16 25-11-16 -
Geüploaded op

25 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00103428

Engels

Eligibility Prostate Cancer NCT00103428

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
metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy)
Beschrijving

Metastatic Prostate Carcinoma Hormone Therapy refractory | Antiandrogen therapy Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C0936223
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C1444662
detectable metastases by bone scan, and/or ct scan, and/or mri, and/or cxr
Beschrijving

Neoplasm Metastasis Detectable bone scan | Neoplasm Metastasis Detectable CT scan | Neoplasm Metastasis Detectable MRI | Neoplasm Metastasis Detectable Chest X-ray

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3830527
UMLS CUI [1,3]
C0203668
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C3830527
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C3830527
UMLS CUI [3,3]
C0024485
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C3830527
UMLS CUI [4,3]
C0039985
ecog performance status 0-1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
Beschrijving

transitional cell carcinoma of prostate | Small cell carcinoma of prostate | Prostate Neuroendocrine Neoplasm | Squamous cell carcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C2145466
UMLS CUI [2]
C1300585
UMLS CUI [3]
C1335515
UMLS CUI [4]
C1302530
history of deep vein thrombosis or pulmonary embolus
Beschrijving

Deep Vein Thrombosis | Pulmonary Embolism

Datatype

boolean

Alias
UMLS CUI [1]
C0149871
UMLS CUI [2]
C0034065
patients taking anticoagulants (such as coumadin or heparin). the use of aspirin while on study is acceptable.
Beschrijving

Anticoagulants | Coumadin | Heparin | Aspirin

Datatype

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0699129
UMLS CUI [3]
C0019134
UMLS CUI [4]
C0004057
history of a bleeding disorder or recent clinically significant bleeding
Beschrijving

Blood Coagulation Disorders | Hemorrhage Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C2826293
seropositive for hiv
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
history of hepatitis b, hepatitis c, or chronic liver disease
Beschrijving

Hepatitis B | Hepatitis C | Chronic liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0341439
prior gene therapy or immunotherapy
Beschrijving

gene therapy | Immunotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0017296
UMLS CUI [2]
C0021083
prior chemotherapy for prostate cancer
Beschrijving

Chemotherapy Used to Treat Prostate Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1880062
radiation therapy within 4 weeks of the first treatment.
Beschrijving

Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
history of myocardial infarction within 6 months of the first treatment
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
history of cerebrovascular accident
Beschrijving

Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
history of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated stage i or ii cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
Beschrijving

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma of urinary bladder, superficial | TNM clinical staging Treated In complete remission | Malignant Neoplasm In complete remission

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4]
C1336527
UMLS CUI [5,1]
C3258246
UMLS CUI [5,2]
C1522326
UMLS CUI [5,3]
C0677874
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C0677874
evidence of active prostatitis
Beschrijving

prostatitis Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033581
UMLS CUI [1,2]
C0332120
known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
Beschrijving

Hypersensitivity docetaxel | Hypersensitivity Polysorbate 80 Pharmaceutical Formulation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0032601
UMLS CUI [2,3]
C1705957
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Similar models

Eligibility Prostate Cancer NCT00103428

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])
Metastatic Prostate Carcinoma Hormone Therapy refractory | Antiandrogen therapy Discontinued
Item
metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy)
boolean
C0936223 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0279492 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Neoplasm Metastasis Detectable bone scan | Neoplasm Metastasis Detectable CT scan | Neoplasm Metastasis Detectable MRI | Neoplasm Metastasis Detectable Chest X-ray
Item
detectable metastases by bone scan, and/or ct scan, and/or mri, and/or cxr
boolean
C0027627 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C3830527 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C3830527 (UMLS CUI [4,2])
C0039985 (UMLS CUI [4,3])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
transitional cell carcinoma of prostate | Small cell carcinoma of prostate | Prostate Neuroendocrine Neoplasm | Squamous cell carcinoma of prostate
Item
transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
boolean
C2145466 (UMLS CUI [1])
C1300585 (UMLS CUI [2])
C1335515 (UMLS CUI [3])
C1302530 (UMLS CUI [4])
Deep Vein Thrombosis | Pulmonary Embolism
Item
history of deep vein thrombosis or pulmonary embolus
boolean
C0149871 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
Anticoagulants | Coumadin | Heparin | Aspirin
Item
patients taking anticoagulants (such as coumadin or heparin). the use of aspirin while on study is acceptable.
boolean
C0003280 (UMLS CUI [1])
C0699129 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
Blood Coagulation Disorders | Hemorrhage Clinical Significance
Item
history of a bleeding disorder or recent clinically significant bleeding
boolean
C0005779 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
HIV Seropositivity
Item
seropositive for hiv
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C | Chronic liver disease
Item
history of hepatitis b, hepatitis c, or chronic liver disease
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0341439 (UMLS CUI [3])
gene therapy | Immunotherapy
Item
prior gene therapy or immunotherapy
boolean
C0017296 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
Chemotherapy Used to Treat Prostate Carcinoma
Item
prior chemotherapy for prostate cancer
boolean
C1880062 (UMLS CUI [1])
Therapeutic radiology procedure
Item
radiation therapy within 4 weeks of the first treatment.
boolean
C1522449 (UMLS CUI [1])
Myocardial Infarction
Item
history of myocardial infarction within 6 months of the first treatment
boolean
C0027051 (UMLS CUI [1])
Cerebrovascular accident
Item
history of cerebrovascular accident
boolean
C0038454 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma of urinary bladder, superficial | TNM clinical staging Treated In complete remission | Malignant Neoplasm In complete remission
Item
history of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated stage i or ii cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C1336527 (UMLS CUI [4])
C3258246 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
C0677874 (UMLS CUI [5,3])
C0006826 (UMLS CUI [6,1])
C0677874 (UMLS CUI [6,2])
prostatitis Evidence of
Item
evidence of active prostatitis
boolean
C0033581 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Hypersensitivity docetaxel | Hypersensitivity Polysorbate 80 Pharmaceutical Formulation
Item
known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
boolean
C0020517 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C1705957 (UMLS CUI [2,3])
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