ID

36964

Beschrijving

Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists; ODM derived from: https://clinicaltrials.gov/show/NCT02475057

Link

https://clinicaltrials.gov/show/NCT02475057

Trefwoorden

Versies (2)
  1. 24-06-19 24-06-19 -
  2. 24-06-19 24-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 juni 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02475057

Engels

Eligibility Prostatic Neoplasms NCT02475057

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer.
Beschrijving

Gender | Prostate carcinoma Advanced Locally | Metastatic Prostate Carcinoma | High risk Prostate carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0600139
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [3]
C0936223
UMLS CUI [4,1]
C0332167
UMLS CUI [4,2]
C0600139
scheduled to start adt for a period of at least one year.
Beschrijving

Antiandrogen therapy Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0205539
subject has a history of one or more of the following:
Beschrijving

Patient Criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0243161
1. myocardial infarction
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
2. ischaemic or haemorrhagic cerebrovascular conditions
Beschrijving

Ischemic cerebrovascular disease | Hemorrhagic cerebrovascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C4478520
UMLS CUI [2]
C4478521
3. arterial embolic and thrombotic events,
Beschrijving

Arterial embolus and thrombosis

Datatype

boolean

Alias
UMLS CUI [1]
C0155749
4. ischaemic heart disease
Beschrijving

Myocardial Ischemia

Datatype

boolean

Alias
UMLS CUI [1]
C0151744
5. prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)
Beschrijving

Coronary revascularisation Percutaneous | Coronary revascularisation | Artery iliac femoral Revascularization

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C0522523
UMLS CUI [2]
C0877341
UMLS CUI [3,1]
C0003842
UMLS CUI [3,2]
C0020889
UMLS CUI [3,3]
C0015811
UMLS CUI [3,4]
C0581603
6. peripheral vascular disease (e.g. significant stenosis (abpi<0.9), claudication, prior vascular surgery/intervention)
Beschrijving

Peripheral Vascular Disease | Stenosis ABPI | Claudication | Vascular Surgical Procedures | Peripheral Vascular Intervention

Datatype

boolean

Alias
UMLS CUI [1]
C0085096
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C1276055
UMLS CUI [3]
C1456822
UMLS CUI [4]
C0042381
UMLS CUI [5]
C3897943
life expectancy of over 12 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
who performance status of 0-2
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
subject is able and has agreed to sign a consent form.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior use of adt. however, prior use of anti-androgens such as casodex, chimax, drogenil, and cyprostat will be allowed.
Beschrijving

Antiandrogen therapy Previous | Casodex allowed | Chimax allowed | Eulexin allowed | Cyprostat allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0591237
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0595574
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0591412
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0591314
UMLS CUI [5,2]
C0683607
prior use of dutasteride/finasteride in past 6 months
Beschrijving

Dutasteride | Finasteride

Datatype

boolean

Alias
UMLS CUI [1]
C0754659
UMLS CUI [2]
C0060389
known allergic reaction to degarelix.
Beschrijving

Allergic Reaction Degarelix

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1455035
any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
Beschrijving

Psychological Factors Limiting Protocol Compliance | Factor Familial Limiting Protocol Compliance | Sociological Factors Limiting Protocol Compliance | Geographic Factors Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033898
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0439801
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
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Similar models

Eligibility Prostatic Neoplasms NCT02475057

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Prostate carcinoma Advanced Locally | Metastatic Prostate Carcinoma | High risk Prostate carcinoma
Item
male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer.
boolean
C0079399 (UMLS CUI [1])
C0600139 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0936223 (UMLS CUI [3])
C0332167 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
Antiandrogen therapy Scheduled
Item
scheduled to start adt for a period of at least one year.
boolean
C0279492 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Patient Criteria
Item
subject has a history of one or more of the following:
boolean
C0030705 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Myocardial Infarction
Item
1. myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Ischemic cerebrovascular disease | Hemorrhagic cerebrovascular disease
Item
2. ischaemic or haemorrhagic cerebrovascular conditions
boolean
C4478520 (UMLS CUI [1])
C4478521 (UMLS CUI [2])
Arterial embolus and thrombosis
Item
3. arterial embolic and thrombotic events,
boolean
C0155749 (UMLS CUI [1])
Myocardial Ischemia
Item
4. ischaemic heart disease
boolean
C0151744 (UMLS CUI [1])
Coronary revascularisation Percutaneous | Coronary revascularisation | Artery iliac femoral Revascularization
Item
5. prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)
boolean
C0877341 (UMLS CUI [1,1])
C0522523 (UMLS CUI [1,2])
C0877341 (UMLS CUI [2])
C0003842 (UMLS CUI [3,1])
C0020889 (UMLS CUI [3,2])
C0015811 (UMLS CUI [3,3])
C0581603 (UMLS CUI [3,4])
Peripheral Vascular Disease | Stenosis ABPI | Claudication | Vascular Surgical Procedures | Peripheral Vascular Intervention
Item
6. peripheral vascular disease (e.g. significant stenosis (abpi<0.9), claudication, prior vascular surgery/intervention)
boolean
C0085096 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C1276055 (UMLS CUI [2,2])
C1456822 (UMLS CUI [3])
C0042381 (UMLS CUI [4])
C3897943 (UMLS CUI [5])
Life Expectancy
Item
life expectancy of over 12 months.
boolean
C0023671 (UMLS CUI [1])
WHO performance status scale
Item
who performance status of 0-2
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
subject is able and has agreed to sign a consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antiandrogen therapy Previous | Casodex allowed | Chimax allowed | Eulexin allowed | Cyprostat allowed
Item
prior use of adt. however, prior use of anti-androgens such as casodex, chimax, drogenil, and cyprostat will be allowed.
boolean
C0279492 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0591237 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0595574 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0591412 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0591314 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
Dutasteride | Finasteride
Item
prior use of dutasteride/finasteride in past 6 months
boolean
C0754659 (UMLS CUI [1])
C0060389 (UMLS CUI [2])
Allergic Reaction Degarelix
Item
known allergic reaction to degarelix.
boolean
C1527304 (UMLS CUI [1,1])
C1455035 (UMLS CUI [1,2])
Psychological Factors Limiting Protocol Compliance | Factor Familial Limiting Protocol Compliance | Sociological Factors Limiting Protocol Compliance | Geographic Factors Limiting Protocol Compliance
Item
any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
boolean
C0033898 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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