ID

36565

Descripción

Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02137746

Link

https://clinicaltrials.gov/show/NCT02137746

Palabras clave

Versiones (2)
  1. 17/1/19 17/1/19 -
  2. 22/5/19 22/5/19 -
Titular de derechos de autor

Sotio a.s.

Subido en

22 de mayo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Second Cycle of DCVAC in Localized Prostate Cancer NCT02137746

Inglés

Eligibility Criteria

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
male 18 years and older
Descripción

Gender and Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically confirmed prostate adenocarcinoma stage pathological tumor-2 (pT2)
Descripción

histologically confirmed prostate adenocarcinoma (pT staged)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0007112
UMLS CUI [2,1]
C0443276
UMLS CUI [2,2]
C0475455
post radical primary prostatectomy
Descripción

post radical primary prostatectomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0194810
completion of DCVAC/PCa arm in study SP003, without objective progression of the disease
Descripción

completion of DCVAC/PCa arm in prior study, without objective progression of the disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3897817
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0242656
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior androgen deprivation therapy for prostate cancer
Descripción

prior androgen deprivation therapy for prostate cancer

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0279492
UMLS CUI [1,3]
C0600139
peripheral neuropathy of common toxicity criteria (CTC) grade 2 or greater
Descripción

peripheral neuropathy (Common Toxicity Criteria)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2,1]
C1516728
UMLS CUI [2,2]
C0441800
other uncontrolled intercurrent illness
Descripción

other uncontrolled intercurrent illness

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205318
UMLS CUI [1,2]
C3640977
treatment with immunotherapy against PCa
Descripción

treatment with immunotherapy against PCa

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0600139
clinically significant cardiovascular disease
Descripción

clinically significant cardiovascular disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2826293
active autoimmune disease requiring treatment
Descripción

active autoimmune disease requiring treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0004364
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
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Similar models

Eligibility Criteria

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender and Age
Item
male 18 years and older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
histologically confirmed prostate adenocarcinoma (pT staged)
Item
histologically confirmed prostate adenocarcinoma stage pathological tumor-2 (pT2)
boolean
C0679557 (UMLS CUI [1,1])
C0007112 (UMLS CUI [1,2])
C0443276 (UMLS CUI [2,1])
C0475455 (UMLS CUI [2,2])
post radical primary prostatectomy
Item
post radical primary prostatectomy
boolean
C0231290 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
completion of DCVAC/PCa arm in prior study, without objective progression of the disease
Item
completion of DCVAC/PCa arm in study SP003, without objective progression of the disease
boolean
C2348568 (UMLS CUI [1,1])
C3897817 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
prior androgen deprivation therapy for prostate cancer
Item
prior androgen deprivation therapy for prostate cancer
boolean
C0205156 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
peripheral neuropathy (Common Toxicity Criteria)
Item
peripheral neuropathy of common toxicity criteria (CTC) grade 2 or greater
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
other uncontrolled intercurrent illness
Item
other uncontrolled intercurrent illness
boolean
C0205318 (UMLS CUI [1,1])
C3640977 (UMLS CUI [1,2])
treatment with immunotherapy against PCa
Item
treatment with immunotherapy against PCa
boolean
C0021083 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
clinically significant cardiovascular disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
active autoimmune disease requiring treatment
Item
active autoimmune disease requiring treatment
boolean
C0205177 (UMLS CUI [1,1])
C0004364 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
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