ID

22622

Description

Study of Robotic Template Guidance for Needle Placement in Transperineal Prostate Brachytherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00381966

Link

https://clinicaltrials.gov/show/NCT00381966

Keywords

Versions (1)
  1. 6/8/17 6/8/17 -
Uploaded on

June 8, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00381966

English

Eligibility Prostate Cancer NCT00381966

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria are unchanged from our standard criteria for brachytherapy eligibility:
Description

Eligibility criteria Standard Brachytherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0006098
histologically confirmed, locally confined adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate Local

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0205276
clinical stages t1b - t2b
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
psa of less than 20 ng/ml
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
combined gleason score 7 or less, with no individual gleason score of 5
Description

Gleason score Combined | Gleason score Individual

Data type

boolean

Alias
UMLS CUI [1,1]
C3203027
UMLS CUI [1,2]
C0205195
UMLS CUI [2,1]
C3203027
UMLS CUI [2,2]
C0021228
the patient has decided to undergo brachytherapy at the johns hopkins hospital as treatment choice for his prostate cancer.
Description

Brachytherapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C0600139
karnofsky performance status > 70
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
prostate volume by trus < 50 cc
Description

Prostate volume Transrectal ultrasound

Data type

boolean

Alias
UMLS CUI [1,1]
C1441416
UMLS CUI [1,2]
C0373345
international prostate symptom score (ipss) must be 18 or less
Description

International prostate symptom score

Data type

boolean

Alias
UMLS CUI [1]
C1998280
signed study-specific consent form prior to registration
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage t1a, or t3 or greater disease.
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
clinical or pathological lymph node involvement (n1).
Description

Lymph Node Involvement TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0806692
UMLS CUI [1,2]
C3258246
evidence of distant metastases (m1).
Description

Distant metastasis Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332120
radical surgery for carcinoma of the prostate.
Description

Operative Surgical Procedure Radical Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0439807
UMLS CUI [1,3]
C0600139
previous chemotherapy or pelvic radiation therapy
Description

Chemotherapy | Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1536155
previous transurethral resection of the prostate (turp)
Description

Transurethral Resection of Prostate

Data type

boolean

Alias
UMLS CUI [1]
C0040771
significant obstructive symptoms (ipss greater than 18)
Description

OBSTRUCTIVE SYMPTOM International prostate symptom score

Data type

boolean

Alias
UMLS CUI [1,1]
C0746983
UMLS CUI [1,2]
C1998280
hip prosthesis.
Description

Hip prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0019560
anatomic or medical condition (such as prior abdominal-perineal resection or anal stricture) which would preclude the use of trus
Description

Condition anatomic Excludes Transrectal ultrasound | Medical condition Excludes Transrectal ultrasound | Abdominoperineal resection | Stricture of anus

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0220784
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0373345
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0373345
UMLS CUI [3]
C2004459
UMLS CUI [4]
C0262374
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Similar models

Eligibility Prostate Cancer NCT00381966

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Eligibility criteria Standard Brachytherapy
Item
inclusion criteria are unchanged from our standard criteria for brachytherapy eligibility:
boolean
C1512693 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0006098 (UMLS CUI [1,3])
Adenocarcinoma of prostate Local
Item
histologically confirmed, locally confined adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
TNM clinical staging
Item
clinical stages t1b - t2b
boolean
C3258246 (UMLS CUI [1])
Prostate specific antigen measurement
Item
psa of less than 20 ng/ml
boolean
C0201544 (UMLS CUI [1])
Gleason score Combined | Gleason score Individual
Item
combined gleason score 7 or less, with no individual gleason score of 5
boolean
C3203027 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C3203027 (UMLS CUI [2,1])
C0021228 (UMLS CUI [2,2])
Brachytherapy Prostate carcinoma
Item
the patient has decided to undergo brachytherapy at the johns hopkins hospital as treatment choice for his prostate cancer.
boolean
C0006098 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Karnofsky Performance Status
Item
karnofsky performance status > 70
boolean
C0206065 (UMLS CUI [1])
Prostate volume Transrectal ultrasound
Item
prostate volume by trus < 50 cc
boolean
C1441416 (UMLS CUI [1,1])
C0373345 (UMLS CUI [1,2])
International prostate symptom score
Item
international prostate symptom score (ipss) must be 18 or less
boolean
C1998280 (UMLS CUI [1])
Informed Consent
Item
signed study-specific consent form prior to registration
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease TNM clinical staging
Item
stage t1a, or t3 or greater disease.
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Lymph Node Involvement TNM clinical staging
Item
clinical or pathological lymph node involvement (n1).
boolean
C0806692 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Distant metastasis Evidence of
Item
evidence of distant metastases (m1).
boolean
C1269798 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Operative Surgical Procedure Radical Prostate carcinoma
Item
radical surgery for carcinoma of the prostate.
boolean
C0543467 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Chemotherapy | Radiotherapy to pelvis
Item
previous chemotherapy or pelvic radiation therapy
boolean
C0392920 (UMLS CUI [1])
C1536155 (UMLS CUI [2])
Transurethral Resection of Prostate
Item
previous transurethral resection of the prostate (turp)
boolean
C0040771 (UMLS CUI [1])
OBSTRUCTIVE SYMPTOM International prostate symptom score
Item
significant obstructive symptoms (ipss greater than 18)
boolean
C0746983 (UMLS CUI [1,1])
C1998280 (UMLS CUI [1,2])
Hip prosthesis
Item
hip prosthesis.
boolean
C0019560 (UMLS CUI [1])
Condition anatomic Excludes Transrectal ultrasound | Medical condition Excludes Transrectal ultrasound | Abdominoperineal resection | Stricture of anus
Item
anatomic or medical condition (such as prior abdominal-perineal resection or anal stricture) which would preclude the use of trus
boolean
C0348080 (UMLS CUI [1,1])
C0220784 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0373345 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0373345 (UMLS CUI [2,3])
C2004459 (UMLS CUI [3])
C0262374 (UMLS CUI [4])
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