ID

31585

Description

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

Link

https://clinicaltrials.gov/show/NCT00715104

Keywords

Versions (1)
  1. 9/8/18 9/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 8, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostate Cancer NCT00715104

English

Eligibility Prostate Cancer NCT00715104

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adenocarcinoma of the prostate.
Description

Adenocarcinoma of prostate

Data type

boolean

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

Radical prostatectomy Scheduled | Induction Therapy Prostate carcinoma Localized

Data type

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.
Description

Age

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Hematologic function | Renal function | Liver function

Data type

boolean

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

Exclusion Criteria

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

Neoplasm Metastasis

Data type

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.
Description

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

Data type

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.
Description

Prior radiation therapy Prostate carcinoma | Prior Chemotherapy Prostate carcinoma

Data type

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.
Description

Steroid therapy Systemic

Data type

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.
Description

Malignant Neoplasms TNM clinical staging | Exception Prostate carcinoma

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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
Back to the top of the page

Similar models

Eligibility Prostate Cancer NCT00715104

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial