ID

4883

Description

ODM derived from http://clinicaltrials.gov/show/NCT00273338

Link

http://clinicaltrials.gov/show/NCT00273338

Keywords

Versions (2)
  1. 2/27/12 2/27/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00003880 NCT00273338 Prostate Cancer

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age >= 18 years
Description

Age

Data type

boolean

Histopathologically or cytologically proven adenocarcinoma of the prostate
Description

adenocarcinoma of the prostate

Data type

boolean

Documented metastatic prostate adenocarcinoma
Description

metastatic prostate adenocarcinoma

Data type

boolean

Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
Description

progression while on androgen ablation therapy

Data type

boolean

Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Description

ECOG performance status <= 2

Data type

boolean

Adequate hematologic, renal and hepatic function
Description

Adequate hematologic, renal and hepatic function

Data type

boolean

Life expectancy >= 3 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Prior chemotherapy, except estramustine
Description

chemotherapy, except estramustine

Data type

boolean

Prior chemotherapy with docetaxel
Description

chemotherapy with docetaxel

Data type

boolean

Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
Description

isotope therapy

Data type

boolean

One or more contraindications to the use of corticosteroids
Description

contraindications to the use of corticosteroids

Data type

boolean

History of cancer-related hypercalcemia
Description

cancer-related hypercalcemia

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Prostate Adenocarcinoma
Description

Prostate Adenocarcinoma

Data type

string

Alias
UMLS CUI
C0007112
SNOMED CT 2010_0731
399490008
MedDRA 13.1
10060862
Metastatic prostate cancer
Description

Metastatic prostate cancer

Data type

string

Alias
UMLS CUI
C0936223
MedDRA 13.1
10036909
Course of illness
Description

Disease Progression

Data type

string

Alias
UMLS CUI
C0242656
SNOMED CT 2010_0731
246453008
MedDRA 13.1
10061818
androgen ablation therapy
Description

androgen ablation therapy

Data type

string

Alias
UMLS CUI
CL382748
Prostate-Specific Antigen
Description

PSA

Data type

string

Alias
UMLS CUI
C0138741
SNOMED CT 2010_0731
102687007
LOINC Version 232
MTHU001466
Diagnostic Imaging
Description

Imaging

Data type

string

Alias
UMLS CUI
C0011923
SNOMED CT 2010_0731
363679005
ECOG performance status - grade 0
Description

ECOG performance status - grade 0

Data type

string

Alias
UMLS CUI
C1828078
SNOMED CT 2010_0731
425389002
ECOG performance status - grade 1
Description

ECOG performance status - grade 1

Data type

string

Alias
UMLS CUI
C1827388
SNOMED CT 2010_0731
422512005
ECOG performance status - grade 2
Description

ECOG performance status - grade 2

Data type

string

Alias
UMLS CUI
C1828242
SNOMED CT 2010_0731
422894000
Hematologic function
Description

Hematologic function

Data type

string

Alias
UMLS CUI
C0221130
SNOMED CT 2010_0731
86084001
kidney function
Description

Renal function

Data type

string

Alias
UMLS CUI
C0232805
SNOMED CT 2010_0731
11953005
Hepatic function
Description

Liver function

Data type

string

Alias
UMLS CUI
C0232741
SNOMED CT 2010_0731
79036002
Chemotherapy
Description

Chemotherapy

Data type

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Estramustine (substance)
Description

Estramustine

Data type

string

Alias
UMLS CUI
C0014921
SNOMED CT 2010_0731
386909008
Taxotere
Description

Docetaxel

Data type

string

Alias
UMLS CUI
C0699967
SNOMED CT 2010_0731
386918005
radioisotope therapy
Description

radioisotope therapy

Data type

string

Alias
UMLS CUI
C0543487
Strontium 89 therapy
Description

Sr89 therapy

Data type

string

Alias
UMLS CUI
C0454108
SNOMED CT 2010_0731
228701001
Samarium 153
Description

Sm-153

Data type

string

Alias
UMLS CUI
C0677942
SNOMED CT 2010_0731
419804008
Contraindication to medical treatment
Description

Contraindication to medical treatment

Data type

string

Alias
UMLS CUI
C1301624
MedDRA 13.1
10010833
Therapeutic Corticosteroid
Description

Corticosteroids

Data type

string

Alias
UMLS CUI
C0001617
SNOMED CT 2010_0731
79440004
Hypercalcemia
Description

hypercalcaemia

Data type

string

Alias
UMLS CUI
C0020437
SNOMED CT 2010_0731
66931009
MedDRA 13.1
10020583
ICD-10-CM Version 2010
E83.52
ICD-9-CM Version 2011
275.42
CTCAE Version 4.03
E12270
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age >= 18 years
boolean
adenocarcinoma of the prostate
Item
Histopathologically or cytologically proven adenocarcinoma of the prostate
boolean
metastatic prostate adenocarcinoma
Item
Documented metastatic prostate adenocarcinoma
boolean
progression while on androgen ablation therapy
Item
Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
boolean
ECOG performance status <= 2
Item
Eastern Cooperative Oncology Group (ECOG) performance status <= 2
boolean
Adequate hematologic, renal and hepatic function
Item
Adequate hematologic, renal and hepatic function
boolean
Life expectancy
Item
Life expectancy >= 3 months
boolean
C0001779 (UMLS CUI)
Item Group
Exclusion Criteria
chemotherapy, except estramustine
Item
Prior chemotherapy, except estramustine
boolean
chemotherapy with docetaxel
Item
Prior chemotherapy with docetaxel
boolean
isotope therapy
Item
Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
boolean
contraindications to the use of corticosteroids
Item
One or more contraindications to the use of corticosteroids
boolean
cancer-related hypercalcemia
Item
History of cancer-related hypercalcemia
boolean
Item Group
Medical Concepts
Age
Item
Age
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Prostate Adenocarcinoma
Item
Prostate Adenocarcinoma
string
C0007112 (UMLS CUI)
399490008 (SNOMED CT 2010_0731)
10060862 (MedDRA 13.1)
Metastatic prostate cancer
Item
Metastatic prostate cancer
string
C0936223 (UMLS CUI)
10036909 (MedDRA 13.1)
Disease Progression
Item
Course of illness
string
C0242656 (UMLS CUI)
246453008 (SNOMED CT 2010_0731)
10061818 (MedDRA 13.1)
androgen ablation therapy
Item
androgen ablation therapy
string
CL382748 (UMLS CUI)
PSA
Item
Prostate-Specific Antigen
string
C0138741 (UMLS CUI)
102687007 (SNOMED CT 2010_0731)
MTHU001466 (LOINC Version 232)
Imaging
Item
Diagnostic Imaging
string
C0011923 (UMLS CUI)
363679005 (SNOMED CT 2010_0731)
ECOG performance status - grade 0
Item
ECOG performance status - grade 0
string
C1828078 (UMLS CUI)
425389002 (SNOMED CT 2010_0731)
ECOG performance status - grade 1
Item
ECOG performance status - grade 1
string
C1827388 (UMLS CUI)
422512005 (SNOMED CT 2010_0731)
ECOG performance status - grade 2
Item
ECOG performance status - grade 2
string
C1828242 (UMLS CUI)
422894000 (SNOMED CT 2010_0731)
Hematologic function
Item
Hematologic function
string
C0221130 (UMLS CUI)
86084001 (SNOMED CT 2010_0731)
Renal function
Item
kidney function
string
C0232805 (UMLS CUI)
11953005 (SNOMED CT 2010_0731)
Liver function
Item
Hepatic function
string
C0232741 (UMLS CUI)
79036002 (SNOMED CT 2010_0731)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Estramustine
Item
Estramustine (substance)
string
C0014921 (UMLS CUI)
386909008 (SNOMED CT 2010_0731)
Docetaxel
Item
Taxotere
string
C0699967 (UMLS CUI)
386918005 (SNOMED CT 2010_0731)
radioisotope therapy
Item
radioisotope therapy
string
C0543487 (UMLS CUI)
Sr89 therapy
Item
Strontium 89 therapy
string
C0454108 (UMLS CUI)
228701001 (SNOMED CT 2010_0731)
Sm-153
Item
Samarium 153
string
C0677942 (UMLS CUI)
419804008 (SNOMED CT 2010_0731)
Contraindication to medical treatment
Item
Contraindication to medical treatment
string
C1301624 (UMLS CUI)
10010833 (MedDRA 13.1)
Corticosteroids
Item
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
hypercalcaemia
Item
Hypercalcemia
string
C0020437 (UMLS CUI)
66931009 (SNOMED CT 2010_0731)
10020583 (MedDRA 13.1)
E83.52 (ICD-10-CM Version 2010)
275.42 (ICD-9-CM Version 2011)
E12270 (CTCAE Version 4.03)
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