ID

36889

Beschrijving

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

Trefwoorden

  1. 18-06-19 18-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 juni 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT02391051

Eligibility Prostate Cancer NCT02391051

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18
Beschrijving

Age

Datatype

boolean

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

Prostate carcinoma

Datatype

boolean

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

Index Lesion Gleason score

Datatype

boolean

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

Tumor TNM clinical staging

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

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

Prostate volume

Datatype

boolean

Alias
UMLS CUI [1]
C1441416
no distant metastasis
Beschrijving

Distant metastasis Absent

Datatype

boolean

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

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor stage ≥ t2b
Beschrijving

Tumor TNM clinical staging

Datatype

boolean

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

Neoplasm Metastasis TNM clinical staging

Datatype

boolean

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

General Anesthesia Unsuccessful | Epidural Anesthesia Unsuccessful

Datatype

boolean

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

Blood Coagulation Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0005779

Similar models

Eligibility Prostate Cancer NCT02391051

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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