ID

36899

Beschreibung

Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT02454543

Link

https://clinicaltrials.gov/show/NCT02454543

Stichworte

Versionen (1)
  1. 19.06.19 19.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

19. Juni 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Prostate Cancer NCT02454543

Englisch

Eligibility Prostate Cancer NCT02454543

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ability to provide written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
newly diagnosed, histologically confirmed adenocarcinoma of the prostate within the last 3 months prior to randomization
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
at least one and at most three bone metastases in imaging studies (bone scintigraphy, mri, pet-ct) and no evidence of visceral metastasis. patients with evidence of lymph node metastasis (n1) are allowed
Beschreibung

Secondary malignant neoplasm of bone Quantity Imaging studies | Bone scintigraphy | MRI | PET/CT scan | Neoplasm Metastasis Visceral Absent | Secondary malignant neoplasm of lymph node

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1881134
UMLS CUI [2]
C3889015
UMLS CUI [3]
C0024485
UMLS CUI [4]
C1699633
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0442045
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C0686619
prostate-specific antigen (psa) <150 ng / ml at diagnosis (without systemic therapy)
Beschreibung

Prostate specific antigen measurement | Systemic therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0332197
asymptomatic or mild symptomatic disease
Beschreibung

Asymptomatic Disease | Disease Symptomatic Mild

Datentyp

boolean

Alias
UMLS CUI [1]
C2936329
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C2945599
local respectable tumor stage defined as clinical stage ≤ t3 based on the results of the digital rectal examination or pelvic imaging
Beschreibung

Local cancer Resectable TNM clinical staging | Digital Rectal Examination | Imaging of pelvis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0796563
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C1384593
UMLS CUI [3]
C3703842
eastern cooperative oncology group (ecog) performance status 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
age ≥ 18 - ≤ 75 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications to radical prostatectomy (local not resectable disease, increased anesthetic risk with co-morbidity)
Beschreibung

Medical contraindication Radical prostatectomy | Local disease unresectable | Comorbidity At risk of complication of anesthesia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0194810
UMLS CUI [2,1]
C0277565
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C4544425
detection of more than 3 bone metastases
Beschreibung

Secondary malignant neoplasm of bone Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C1265611
previous radiation therapy of symptomatic bone metastases
Beschreibung

Prior radiation therapy Secondary malignant neoplasm of bone Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0153690
UMLS CUI [1,3]
C0231220
pain management with opioid analgesics
Beschreibung

Pain management | Analgesics, Opioid

Datentyp

boolean

Alias
UMLS CUI [1]
C0002766
UMLS CUI [2]
C0002772
detection of visceral metastases or brain metastases
Beschreibung

Neoplasm Metastasis Visceral | Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
UMLS CUI [2]
C0220650
neuroendocrine and / or small cell differentiation in histology of the biopsy
Beschreibung

Neuroendocrine Differentiation | Cell Small Differentiation | Histology Biopsy

Datentyp

boolean

Alias
UMLS CUI [1]
C1709218
UMLS CUI [2,1]
C0007634
UMLS CUI [2,2]
C0700321
UMLS CUI [2,3]
C0007589
UMLS CUI [3,1]
C0344441
UMLS CUI [3,2]
C0005558
charlson comorbidity index > 2
Beschreibung

Charlson Comorbidity Index

Datentyp

boolean

Alias
UMLS CUI [1]
C4546361
ecog performance score > 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
myocardial infarction or stroke within the last 6 months
Beschreibung

Myocardial Infarction | Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
existing major cardiovascular (grade iii - iv according to nyha), pulmonary (po2 <60 mmhg), renal, hepatic or hematopoietic (eg, severe bone marrow aplasia) disease
Beschreibung

Cardiovascular Disease Major New York Heart Association Classification | Lung disease | PO2 measurement | Kidney Disease | Liver disease | Hematological Disease | Bone marrow aplasia Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0024115
UMLS CUI [3]
C1283004
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0018939
UMLS CUI [7,1]
C1368107
UMLS CUI [7,2]
C0205082
severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution
Beschreibung

Mental Disorders, Severe | Institutionalized Persons

Datentyp

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2]
C0376326
simultaneous participation in another clinical trial with interventional character of the metastatic prostate cancer
Beschreibung

Study Subject Participation Status | Interventional Study | Metastatic Prostate Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3]
C0936223
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Prostate Cancer NCT02454543

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
newly diagnosed, histologically confirmed adenocarcinoma of the prostate within the last 3 months prior to randomization
boolean
C0007112 (UMLS CUI [1])
Secondary malignant neoplasm of bone Quantity Imaging studies | Bone scintigraphy | MRI | PET/CT scan | Neoplasm Metastasis Visceral Absent | Secondary malignant neoplasm of lymph node
Item
at least one and at most three bone metastases in imaging studies (bone scintigraphy, mri, pet-ct) and no evidence of visceral metastasis. patients with evidence of lymph node metastasis (n1) are allowed
boolean
C0153690 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1881134 (UMLS CUI [1,3])
C3889015 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C1699633 (UMLS CUI [4])
C0027627 (UMLS CUI [5,1])
C0442045 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0686619 (UMLS CUI [6])
Prostate specific antigen measurement | Systemic therapy Absent
Item
prostate-specific antigen (psa) <150 ng / ml at diagnosis (without systemic therapy)
boolean
C0201544 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Asymptomatic Disease | Disease Symptomatic Mild
Item
asymptomatic or mild symptomatic disease
boolean
C2936329 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C2945599 (UMLS CUI [2,3])
Local cancer Resectable TNM clinical staging | Digital Rectal Examination | Imaging of pelvis
Item
local respectable tumor stage defined as clinical stage ≤ t3 based on the results of the digital rectal examination or pelvic imaging
boolean
C0796563 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1384593 (UMLS CUI [2])
C3703842 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age ≥ 18 - ≤ 75 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Radical prostatectomy | Local disease unresectable | Comorbidity At risk of complication of anesthesia
Item
contraindications to radical prostatectomy (local not resectable disease, increased anesthetic risk with co-morbidity)
boolean
C1301624 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
C0277565 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C4544425 (UMLS CUI [3,2])
Secondary malignant neoplasm of bone Quantity
Item
detection of more than 3 bone metastases
boolean
C0153690 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Prior radiation therapy Secondary malignant neoplasm of bone Symptomatic
Item
previous radiation therapy of symptomatic bone metastases
boolean
C0279134 (UMLS CUI [1,1])
C0153690 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Pain management | Analgesics, Opioid
Item
pain management with opioid analgesics
boolean
C0002766 (UMLS CUI [1])
C0002772 (UMLS CUI [2])
Neoplasm Metastasis Visceral | Metastatic malignant neoplasm to brain
Item
detection of visceral metastases or brain metastases
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
Neuroendocrine Differentiation | Cell Small Differentiation | Histology Biopsy
Item
neuroendocrine and / or small cell differentiation in histology of the biopsy
boolean
C1709218 (UMLS CUI [1])
C0007634 (UMLS CUI [2,1])
C0700321 (UMLS CUI [2,2])
C0007589 (UMLS CUI [2,3])
C0344441 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Charlson Comorbidity Index
Item
charlson comorbidity index > 2
boolean
C4546361 (UMLS CUI [1])
ECOG performance status
Item
ecog performance score > 1
boolean
C1520224 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident
Item
myocardial infarction or stroke within the last 6 months
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Cardiovascular Disease Major New York Heart Association Classification | Lung disease | PO2 measurement | Kidney Disease | Liver disease | Hematological Disease | Bone marrow aplasia Severe
Item
existing major cardiovascular (grade iii - iv according to nyha), pulmonary (po2 <60 mmhg), renal, hepatic or hematopoietic (eg, severe bone marrow aplasia) disease
boolean
C0007222 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0024115 (UMLS CUI [2])
C1283004 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C1368107 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Mental Disorders, Severe | Institutionalized Persons
Item
severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution
boolean
C4046029 (UMLS CUI [1])
C0376326 (UMLS CUI [2])
Study Subject Participation Status | Interventional Study | Metastatic Prostate Carcinoma
Item
simultaneous participation in another clinical trial with interventional character of the metastatic prostate cancer
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C0936223 (UMLS CUI [3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video