ID

18933

Description

Study of CEP-701 in Treatment of Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00081601

Link

https://clinicaltrials.gov/show/NCT00081601

Keywords

Versions (1)
  1. 11/25/16 11/25/16 -
Uploaded on

November 25, 2016

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 NCT00081601

English

Eligibility Prostate Cancer NCT00081601

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 yrs of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
no detectable metastatic disease as assessed by bone and ct scans
Description

Neoplasm Metastasis Detectable | Radioisotope scan of bone | X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3830527
UMLS CUI [2]
C0203668
UMLS CUI [3]
C0040405
has increasing serum psa concentrations
Description

Serum Prostate Specific Antigen Increased

Data type

boolean

Alias
UMLS CUI [1]
C1883014
life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
Description

Antiandrogen therapy Withdrawn

Data type

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0424092
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has asymptomatic disease
Description

Asymptomatic Disease

Data type

boolean

Alias
UMLS CUI [1]
C2936329
has active gi ulceration or bleeding
Description

Gastrointestinal ulcer | Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2]
C0017181
has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
Description

cancer treatment Systemic Hormonal | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0458083
UMLS CUI [2]
C1522449
bilirubin >2x uln or alt or ast >2xuln or serum creatinine >1.5mg/dl
Description

Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201976
hemoglobin <9g/dl or platelets below 100,000/ul or anc below 1500/ul
Description

Hemoglobin | Platelet Count measurement | Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0948762
receiving treatment for hiv with protease inhibitors
Description

HIV Protease Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0162714
has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
Description

Malignant Neoplasms | Basal cell carcinoma Resected | Squamous cell carcinoma of skin Resected

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1521996
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1521996
has used investigational drug with previous one month
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
Back to the top of the page

Similar models

Eligibility Prostate Cancer NCT00081601

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 yrs of age
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis Detectable | Radioisotope scan of bone | X-Ray Computed Tomography
Item
no detectable metastatic disease as assessed by bone and ct scans
boolean
C0027627 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0203668 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
Serum Prostate Specific Antigen Increased
Item
has increasing serum psa concentrations
boolean
C1883014 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Antiandrogen therapy Withdrawn
Item
has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
boolean
C0279492 (UMLS CUI [1,1])
C0424092 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Asymptomatic Disease
Item
has asymptomatic disease
boolean
C2936329 (UMLS CUI [1])
Gastrointestinal ulcer | Gastrointestinal Hemorrhage
Item
has active gi ulceration or bleeding
boolean
C0237938 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
cancer treatment Systemic Hormonal | Therapeutic radiology procedure
Item
has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0458083 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
bilirubin >2x uln or alt or ast >2xuln or serum creatinine >1.5mg/dl
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Hemoglobin | Platelet Count measurement | Absolute neutrophil count
Item
hemoglobin <9g/dl or platelets below 100,000/ul or anc below 1500/ul
boolean
C0019046 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
HIV Protease Inhibitors
Item
receiving treatment for hiv with protease inhibitors
boolean
C0162714 (UMLS CUI [1])
Malignant Neoplasms | Basal cell carcinoma Resected | Squamous cell carcinoma of skin Resected
Item
has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1521996 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1521996 (UMLS CUI [3,2])
Investigational New Drugs
Item
has used investigational drug with previous one month
boolean
C0013230 (UMLS CUI [1])
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