ID

36889

Description

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

Keywords

  1. 6/18/19 6/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 18, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Prostate Cancer NCT02391051

Eligibility Prostate Cancer NCT02391051

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18
Description

Age

Data type

boolean

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

Prostate carcinoma

Data type

boolean

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

Index Lesion Gleason score

Data type

boolean

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

Tumor TNM clinical staging

Data type

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.
Description

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

Data type

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
Description

Prostate specific antigen measurement

Data type

boolean

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

Prostate volume

Data type

boolean

Alias
UMLS CUI [1]
C1441416
no distant metastasis
Description

Distant metastasis Absent

Data type

boolean

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

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor stage ≥ t2b
Description

Tumor TNM clinical staging

Data type

boolean

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

Neoplasm Metastasis TNM clinical staging

Data type

boolean

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

General Anesthesia Unsuccessful | Epidural Anesthesia Unsuccessful

Data type

boolean

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

Blood Coagulation Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005779

Similar models

Eligibility Prostate Cancer NCT02391051

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial