ID

31585

Descrição

Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00715104

Link

https://clinicaltrials.gov/show/NCT00715104

Palavras-chave

Versões (1)
  1. 08/09/2018 08/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00715104

Inglês

Eligibility Prostate Cancer NCT00715104

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adenocarcinoma of the prostate.
Descrição

Adenocarcinoma of prostate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007112
subject is scheduled for rp as the initial therapy for localized prostate cancer.
Descrição

Radical prostatectomy Scheduled | Induction Therapy Prostate carcinoma Localized

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0600139
UMLS CUI [2,3]
C0392752
subject is ≥ 18 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subject has an eastern cooperative oncology group (ecog) performance status of 0 or 1.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
subject has adequate hematologic, renal, and liver function.
Descrição

Hematologic function | Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has any evidence of metastasis.
Descrição

Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027627
subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
Descrição

Hormones | Luteinizing Hormone-releasing Hormone Agonist | Androgen Antagonists | 5-alpha Reductase Inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019932
UMLS CUI [2]
C1518041
UMLS CUI [3]
C0002842
UMLS CUI [4]
C2936788
subject has received prior radiation therapy or chemotherapy for prostate cancer.
Descrição

Prior radiation therapy Prostate carcinoma | Prior Chemotherapy Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0600139
subject has received systemic steroid therapy within 14 days.
Descrição

Steroid therapy Systemic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205373
subject has a history of stage iii or greater cancer, excluding prostate cancer.
Descrição

Malignant Neoplasms TNM clinical staging | Exception Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
Descrição

Basal cell carcinoma Treated allowed | Squamous cell carcinoma of skin Treated allowed | Relationship Disease Free of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007117
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0683607
UMLS CUI [2,1]
C0553723
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
subjects with a history of stage i or ii cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.
Descrição

Malignant Neoplasms Treated TNM clinical staging | Malignant Neoplasms Disease Free of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
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Similar models

Eligibility Prostate Cancer NCT00715104

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Radical prostatectomy Scheduled | Induction Therapy Prostate carcinoma Localized
Item
subject is scheduled for rp as the initial therapy for localized prostate cancer.
boolean
C0194810 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0392752 (UMLS CUI [2,3])
Age
Item
subject is ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
subject has an eastern cooperative oncology group (ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
subject has adequate hematologic, renal, and liver function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
subject has any evidence of metastasis.
boolean
C0027627 (UMLS CUI [1])
Hormones | Luteinizing Hormone-releasing Hormone Agonist | Androgen Antagonists | 5-alpha Reductase Inhibitors
Item
subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
boolean
C0019932 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C0002842 (UMLS CUI [3])
C2936788 (UMLS CUI [4])
Prior radiation therapy Prostate carcinoma | Prior Chemotherapy Prostate carcinoma
Item
subject has received prior radiation therapy or chemotherapy for prostate cancer.
boolean
C0279134 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Steroid therapy Systemic
Item
subject has received systemic steroid therapy within 14 days.
boolean
C0149783 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Malignant Neoplasms TNM clinical staging | Exception Prostate carcinoma
Item
subject has a history of stage iii or greater cancer, excluding prostate cancer.
boolean
C0006826 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Basal cell carcinoma Treated allowed | Squamous cell carcinoma of skin Treated allowed | Relationship Disease Free of
Item
subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
boolean
C0007117 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C0553723 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0439849 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Malignant Neoplasms Treated TNM clinical staging | Malignant Neoplasms Disease Free of
Item
subjects with a history of stage i or ii cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.
boolean
C0006826 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
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