ID

41178

Description

Laser Based Focal Ablation of Low Grade Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01192438

Link

https://clinicaltrials.gov/show/NCT01192438

Keywords

  1. 7/6/20 7/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 6, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 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 Low Grade Prostate Cancer NCT01192438

Eligibility Low Grade Prostate Cancer NCT01192438

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male, 45 years of age or older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosis of prostate adenocarcinoma
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
clinical stage t1c or t2a
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
gleason score of 7 or less
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
a minimum of 12 biopsy cores sampled during diagnostic biopsy
Description

Core needle biopsy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C1265611
three or fewer biopsy cores with prostate cancer
Description

Core needle biopsy Quantity Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0600139
no single biopsy core with greater than 50% of tumor involvement
Description

Core needle biopsy Neoplasm Involvement Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C0027651
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0439165
a radiographically visible prostate lesion on mri with concordance to biopsy sextant
Description

Lesion of prostate MRI | Lesion of prostate Sextant biopsy | Concordance

Data type

boolean

Alias
UMLS CUI [1,1]
C0577255
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0577255
UMLS CUI [2,2]
C3846092
UMLS CUI [3]
C4553529
a documented karnofsky performance status of at least 70
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
estimated survival of 20 years or greater, as determined by treating physician
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ability to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous surgery, radiation, or androgen deprivation therapy for prostate cancer
Description

Operative Surgical Procedure Prostate carcinoma | Therapeutic radiology procedure Prostate carcinoma | Antiandrogen therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0279492
UMLS CUI [3,2]
C0600139
presence of any condition (e.g., metal implant, shrapnel) not compatible with mri
Description

Condition Incompatible MRI | Metallic implant | Shrapnel

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C4698019
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C3693688
UMLS CUI [3]
C0522670
history of previous pelvic radiation
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
severe lower urinary tract symptoms as measured by an international prostate symptom score (ipss) of 20 or greater. (see appendix a)
Description

Lower Urinary Tract Symptoms Severe IPSS

Data type

boolean

Alias
UMLS CUI [1,1]
C0574785
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1998280
history of other primary non-skin malignancy within previous three years
Description

Cancer Other | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893

Similar models

Eligibility Low Grade Prostate Cancer NCT01192438

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
male, 45 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
diagnosis of prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
TNM clinical staging
Item
clinical stage t1c or t2a
boolean
C3258246 (UMLS CUI [1])
Gleason score
Item
gleason score of 7 or less
boolean
C3203027 (UMLS CUI [1])
Core needle biopsy Quantity
Item
a minimum of 12 biopsy cores sampled during diagnostic biopsy
boolean
C1318309 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Core needle biopsy Quantity Prostate carcinoma
Item
three or fewer biopsy cores with prostate cancer
boolean
C1318309 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Core needle biopsy Neoplasm Involvement Percentage
Item
no single biopsy core with greater than 50% of tumor involvement
boolean
C1318309 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Lesion of prostate MRI | Lesion of prostate Sextant biopsy | Concordance
Item
a radiographically visible prostate lesion on mri with concordance to biopsy sextant
boolean
C0577255 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0577255 (UMLS CUI [2,1])
C3846092 (UMLS CUI [2,2])
C4553529 (UMLS CUI [3])
Karnofsky Performance Status
Item
a documented karnofsky performance status of at least 70
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
estimated survival of 20 years or greater, as determined by treating physician
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
ability to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedure Prostate carcinoma | Therapeutic radiology procedure Prostate carcinoma | Antiandrogen therapy Prostate carcinoma
Item
previous surgery, radiation, or androgen deprivation therapy for prostate cancer
boolean
C0543467 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
Condition Incompatible MRI | Metallic implant | Shrapnel
Item
presence of any condition (e.g., metal implant, shrapnel) not compatible with mri
boolean
C0348080 (UMLS CUI [1,1])
C4698019 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C3693688 (UMLS CUI [2])
C0522670 (UMLS CUI [3])
Radiotherapy to pelvis
Item
history of previous pelvic radiation
boolean
C1536155 (UMLS CUI [1])
Lower Urinary Tract Symptoms Severe IPSS
Item
severe lower urinary tract symptoms as measured by an international prostate symptom score (ipss) of 20 or greater. (see appendix a)
boolean
C0574785 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1998280 (UMLS CUI [1,3])
Cancer Other | Exception Skin carcinoma
Item
history of other primary non-skin malignancy within previous three years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])

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