ID

68

Description

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00617669

Link

http://clinicaltrials.gov/ct2/show/record/NCT00617669

Keywords

Versions (6)
  1. 11/15/11 11/15/11 -
  2. 3/23/14 3/23/14 - Martin Dugas
  3. 8/10/14 8/10/14 - Martin Dugas
  4. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  5. 9/20/21 9/20/21 -
  6. 9/28/21 9/28/21 - Sarah Riepenhausen
Uploaded on

November 15, 2011

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00617669 Prostate Cancer

English

Eligibility

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

Inclusion

18 Years and older
Description

Age

Data type

boolean

male
Description

Gender

Data type

boolean

Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
Description

Prostate Ca with bone metastasis

Data type

boolean

Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
Description

PSA increase

Data type

boolean

Currently receiving treatment with surgical or medical castration
Description

Castration

Data type

boolean

Exclusion
Description

Exclusion

Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
Description

Previous chemotherapy

Data type

boolean

Suffering from heart failure or had a myocardial infarction within last 6 months
Description

Heart disease

Data type

boolean

A history of epilepsy or seizures
Description

Epilepsy, seizures

Data type

boolean

Medical concepts
Description

Medical concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Gender
Description

Gender

Data type

string

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LOINC Version 232
MTHU002975
Diagnosis
Description

Diagnosis

Data type

string

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

Cancer of prostate

Data type

string

Alias
UMLS CUI
C0600139
SNOMED CT 2010_0731
254900004
MedDRA 13.1
10036921
Metastatic prostate cancer
Description

Metastatic prostate cancer

Data type

string

Alias
UMLS CUI
C0936223
Metastatic Malignant Neoplasm to the Bone
Description

Bone metastasis

Data type

string

Alias
UMLS CUI
C0153690
SNOMED CT 2010_0731
94222008
MedDRA 13.1
10055101
ICD-10-CM Version 2010
C79.51
ICD-9-CM Version 2011
198.5
Prostate-Specific Antigen
Description

PSA

Data type

string

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

Castration

Data type

string

Alias
UMLS CUI
C0007347
SNOMED CT 2010_0731
275234001
Chemotherapy
Description

Chemotherapy

Data type

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Heart failure
Description

Heart failure

Data type

string

Alias
UMLS CUI
C0018801
SNOMED CT 2010_0731
155374007
MedDRA 13.1
10019279
Acute myocardial infarction
Description

Acute myocardial infarction

Data type

string

Alias
UMLS CUI
C0155626
SNOMED CT 2010_0731
57054005
MedDRA 13.1
10000891
ICD-10-CM Version 2010
I21
ICD-9-CM Version 2011
410
Epilepsia
Description

Epilepsy

Data type

string

Alias
UMLS CUI
C0014544
SNOMED CT 2010_0731
84757009
MedDRA 13.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Convulsion
Description

Seizures

Data type

string

Alias
UMLS CUI
C0036572
SNOMED CT 2010_0731
91175000
MedDRA 13.1
10039910
ICD-9-CM Version 2011
780.39
Past medical history
Description

Medical History

Data type

string

Alias
UMLS CUI
C0262926
SNOMED CT 2010_0731
417662000
LOINC Version 232
MTHU027722
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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
Age
Item
18 Years and older
boolean
Gender
Item
male
boolean
Prostate Ca with bone metastasis
Item
Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
boolean
PSA increase
Item
Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
boolean
Castration
Item
Currently receiving treatment with surgical or medical castration
boolean
Item Group
Exclusion
Previous chemotherapy
Item
Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
boolean
Heart disease
Item
Suffering from heart failure or had a myocardial infarction within last 6 months
boolean
Epilepsy, seizures
Item
A history of epilepsy or seizures
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Gender
Item
Gender
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LOINC Version 232)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Cancer of prostate
Item
Prostate carcinoma
string
C0600139 (UMLS CUI)
254900004 (SNOMED CT 2010_0731)
10036921 (MedDRA 13.1)
Metastatic prostate cancer
Item
Metastatic prostate cancer
string
C0936223 (UMLS CUI)
Bone metastasis
Item
Metastatic Malignant Neoplasm to the Bone
string
C0153690 (UMLS CUI)
94222008 (SNOMED CT 2010_0731)
10055101 (MedDRA 13.1)
C79.51 (ICD-10-CM Version 2010)
198.5 (ICD-9-CM Version 2011)
PSA
Item
Prostate-Specific Antigen
string
C0138741 (UMLS CUI)
102687007 (SNOMED CT 2010_0731)
MTHU001466 (LOINC Version 232)
Castration
Item
Castration
string
C0007347 (UMLS CUI)
275234001 (SNOMED CT 2010_0731)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Heart failure
Item
Heart failure
string
C0018801 (UMLS CUI)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
Acute myocardial infarction
Item
Acute myocardial infarction
string
C0155626 (UMLS CUI)
57054005 (SNOMED CT 2010_0731)
10000891 (MedDRA 13.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
Epilepsy
Item
Epilepsia
string
C0014544 (UMLS CUI)
84757009 (SNOMED CT 2010_0731)
10015037 (MedDRA 13.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Seizures
Item
Convulsion
string
C0036572 (UMLS CUI)
91175000 (SNOMED CT 2010_0731)
10039910 (MedDRA 13.1)
780.39 (ICD-9-CM Version 2011)
Medical History
Item
Past medical history
string
C0262926 (UMLS CUI)
417662000 (SNOMED CT 2010_0731)
MTHU027722 (LOINC Version 232)
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