ID

68

Beschreibung

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

Link

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

Stichworte

Versionen (6)
  1. 15.11.11 15.11.11 -
  2. 23.03.14 23.03.14 - Martin Dugas
  3. 10.08.14 10.08.14 - Martin Dugas
  4. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  5. 20.09.21 20.09.21 -
  6. 28.09.21 28.09.21 - Sarah Riepenhausen
Hochgeladen am

15. November 2011

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00617669 Prostate Cancer

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion
Beschreibung

Inclusion

18 Years and older
Beschreibung

Age

Datentyp

boolean

male
Beschreibung

Gender

Datentyp

boolean

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

Prostate Ca with bone metastasis

Datentyp

boolean

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

PSA increase

Datentyp

boolean

Currently receiving treatment with surgical or medical castration
Beschreibung

Castration

Datentyp

boolean

Exclusion
Beschreibung

Exclusion

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

Previous chemotherapy

Datentyp

boolean

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

Heart disease

Datentyp

boolean

A history of epilepsy or seizures
Beschreibung

Epilepsy, seizures

Datentyp

boolean

Medical concepts
Beschreibung

Medical concepts

Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Gender
Beschreibung

Gender

Datentyp

string

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

Diagnosis

Datentyp

string

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

Cancer of prostate

Datentyp

string

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

Metastatic prostate cancer

Datentyp

string

Alias
UMLS CUI
C0936223
Metastatic Malignant Neoplasm to the Bone
Beschreibung

Bone metastasis

Datentyp

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
Beschreibung

PSA

Datentyp

string

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

Castration

Datentyp

string

Alias
UMLS CUI
C0007347
SNOMED CT 2010_0731
275234001
Chemotherapy
Beschreibung

Chemotherapy

Datentyp

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Medication
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Heart failure
Beschreibung

Heart failure

Datentyp

string

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

Acute myocardial infarction

Datentyp

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
Beschreibung

Epilepsy

Datentyp

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
Beschreibung

Seizures

Datentyp

string

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

Medical History

Datentyp

string

Alias
UMLS CUI
C0262926
SNOMED CT 2010_0731
417662000
LOINC Version 232
MTHU027722
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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