ID

36889

Beschreibung

Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial; ODM derived from: https://clinicaltrials.gov/show/NCT02391051

Link

https://clinicaltrials.gov/show/NCT02391051

Stichworte

Versionen (1)
  1. 18.06.19 18.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02391051

Englisch

Eligibility Prostate Cancer NCT02391051

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed prostate cancer
Beschreibung

Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
gleason score of index lesion ≤ 6 (3+3)
Beschreibung

Index Lesion Gleason score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3829547
UMLS CUI [1,2]
C3203027
tumor stage: ct1-2a cn0 cm0
Beschreibung

Tumor TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. no more than 25% of the punch should be affected. therefore a 3d-tpm-biopsy is mandatory before treatment.
Beschreibung

Unilateral disease | Index Lesion | Lesion Contralateral | Lesion Contralateral Absent | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C4035394
UMLS CUI [2]
C3829547
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0441988
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0441988
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C3846158
psa ≤ 10/ng/ml
Beschreibung

Prostate specific antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
prostate volume < 60 m^3
Beschreibung

Prostate volume

Datentyp

boolean

Alias
UMLS CUI [1]
C1441416
no distant metastasis
Beschreibung

Distant metastasis Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
life expectancy > 10 years
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor stage ≥ t2b
Beschreibung

Tumor TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
known metastasis: n+ and/or m1
Beschreibung

Neoplasm Metastasis TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3258246
general anesthesia or peridural anesthesia is not possible
Beschreibung

General Anesthesia Unsuccessful | Epidural Anesthesia Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002915
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C0002913
UMLS CUI [2,2]
C1272705
coagulation disorder
Beschreibung

Blood Coagulation Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
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Ähnliche Modelle

Eligibility Prostate Cancer NCT02391051

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18
boolean
C0001779 (UMLS CUI [1])
Prostate carcinoma
Item
histologically confirmed prostate cancer
boolean
C0600139 (UMLS CUI [1])
Index Lesion Gleason score
Item
gleason score of index lesion ≤ 6 (3+3)
boolean
C3829547 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
Tumor TNM clinical staging
Item
tumor stage: ct1-2a cn0 cm0
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Unilateral disease | Index Lesion | Lesion Contralateral | Lesion Contralateral Absent | Other Coding
Item
unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. no more than 25% of the punch should be affected. therefore a 3d-tpm-biopsy is mandatory before treatment.
boolean
C4035394 (UMLS CUI [1])
C3829547 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0441988 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0441988 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C3846158 (UMLS CUI [5])
Prostate specific antigen measurement
Item
psa ≤ 10/ng/ml
boolean
C0201544 (UMLS CUI [1])
Prostate volume
Item
prostate volume < 60 m^3
boolean
C1441416 (UMLS CUI [1])
Distant metastasis Absent
Item
no distant metastasis
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy > 10 years
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor TNM clinical staging
Item
tumor stage ≥ t2b
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Neoplasm Metastasis TNM clinical staging
Item
known metastasis: n+ and/or m1
boolean
C0027627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
General Anesthesia Unsuccessful | Epidural Anesthesia Unsuccessful
Item
general anesthesia or peridural anesthesia is not possible
boolean
C0002915 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0002913 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Blood Coagulation Disorder
Item
coagulation disorder
boolean
C0005779 (UMLS CUI [1])
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