ID

31609

Beschrijving

Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00849121

Link

https://clinicaltrials.gov/show/NCT00849121

Trefwoorden

Versies (1)
  1. 12-09-18 12-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 september 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00849121

Engels

Eligibility Prostate Cancer NCT00849121

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of prostate cancer
Beschrijving

Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0600139
castrate resistant disease with rising psa despite continuous treatment with orchiectomy or a lhrh agonist
Beschrijving

Castrate-resistant prostate cancer | Raised prostate specific antigen | Orchiectomy | LHRH Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2]
C0178415
UMLS CUI [3]
C0029189
UMLS CUI [4]
C1518041
rising psa after treatment and withdrawal of anti-androgen
Beschrijving

Raised prostate specific antigen Post Antiandrogen therapy | Raised prostate specific antigen Post Withdrawal Androgen Antagonists

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0279492
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2349954
UMLS CUI [2,4]
C0002842
serum testosterone <50ng/ml
Beschrijving

Serum testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0428413
normal organ function per laboratory tests
Beschrijving

Organ function Laboratory Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0022885
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no evidence of immunosuppression or on treatment with immunosuppressive agents
Beschrijving

Immunosuppression | Therapeutic immunosuppression

Datatype

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021079
cannot have discontinued lhrh agonist treatment (if not previously treated by orchiectomy) within 6 months prior to study entry
Beschrijving

LHRH Agonist Discontinued | Exception Orchiectomy Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518041
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0029189
UMLS CUI [2,3]
C0205156
must not be concurrently taking other medications or supplements with known hormonal effects (other than the lhrh agonist noted above).
Beschrijving

Pharmaceutical Preparations Effect Hormonal | Supplements Effect Hormonal | Exception LHRH Agonist

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0458083
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C0458083
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1518041
cannot have any evidence for metastatic disease on bone or ct scan
Beschrijving

Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0040405
unable or unwilling to undergo two leukapheresis procedure
Beschrijving

Leukapheresis Quantity Unable | Leukapheresis Quantity Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023416
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0023416
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Prostate Cancer NCT00849121

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
diagnosis of prostate cancer
boolean
C0600139 (UMLS CUI [1])
Castrate-resistant prostate cancer | Raised prostate specific antigen | Orchiectomy | LHRH Agonist
Item
castrate resistant disease with rising psa despite continuous treatment with orchiectomy or a lhrh agonist
boolean
C1328504 (UMLS CUI [1])
C0178415 (UMLS CUI [2])
C0029189 (UMLS CUI [3])
C1518041 (UMLS CUI [4])
Raised prostate specific antigen Post Antiandrogen therapy | Raised prostate specific antigen Post Withdrawal Androgen Antagonists
Item
rising psa after treatment and withdrawal of anti-androgen
boolean
C0178415 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0279492 (UMLS CUI [1,3])
C0178415 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2349954 (UMLS CUI [2,3])
C0002842 (UMLS CUI [2,4])
Serum testosterone measurement
Item
serum testosterone <50ng/ml
boolean
C0428413 (UMLS CUI [1])
Organ function Laboratory Procedures
Item
normal organ function per laboratory tests
boolean
C0678852 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Immunosuppression | Therapeutic immunosuppression
Item
no evidence of immunosuppression or on treatment with immunosuppressive agents
boolean
C4048329 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
LHRH Agonist Discontinued | Exception Orchiectomy Previous
Item
cannot have discontinued lhrh agonist treatment (if not previously treated by orchiectomy) within 6 months prior to study entry
boolean
C1518041 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0029189 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
Pharmaceutical Preparations Effect Hormonal | Supplements Effect Hormonal | Exception LHRH Agonist
Item
must not be concurrently taking other medications or supplements with known hormonal effects (other than the lhrh agonist noted above).
boolean
C0013227 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0458083 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C0458083 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1518041 (UMLS CUI [3,2])
Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT scan
Item
cannot have any evidence for metastatic disease on bone or ct scan
boolean
C0027627 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Leukapheresis Quantity Unable | Leukapheresis Quantity Unwilling
Item
unable or unwilling to undergo two leukapheresis procedure
boolean
C0023416 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0023416 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
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