ID

31609

Descrição

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

Palavras-chave

  1. 12/09/2018 12/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

12 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT00849121

Eligibility Prostate Cancer NCT00849121

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of prostate cancer
Descrição

Prostate carcinoma

Tipo de dados

boolean

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

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Serum testosterone measurement

Tipo de dados

boolean

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

Organ function Laboratory Procedures

Tipo de dados

boolean

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

Exclusion Criteria

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

Immunosuppression | Therapeutic immunosuppression

Tipo de dados

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
Descrição

LHRH Agonist Discontinued | Exception Orchiectomy Previous

Tipo de dados

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).
Descrição

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

Tipo de dados

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
Descrição

Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT scan

Tipo de dados

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
Descrição

Leukapheresis Quantity Unable | Leukapheresis Quantity Unwilling

Tipo de dados

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

Similar models

Eligibility Prostate Cancer NCT00849121

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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